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

Principal Investigator’s Team
Coordinator: Federico Martinón-Torres
Research coordinator / Regulatory: Carmen Rodríguez-Tenreiro Sánchez
Vaccine Trial Unit Clinic Coordinator: Lorenzo Redondo Collazo
Investigators: Blanca Díaz Esteban
Marta Lendoiro Fuentes
Montserrat López Franco
Carolina López Sanguos
Ana Isabel Dacosta Urbieta
Jose María Martinón Sánchez
Rosaura Picáns Leis
Andrés Pérez Muy
Iván Prieto Gómez
Irene Rivero Calle
Javier Trastoy Quintela
Gloria Viz Rodríguez
Collaborating Sub-investigators: Juan Sánchez Lastres
Consuelo Alonso Alonso
Marta Carballal Mariño
Lucía Castro Paz
Mercedes Del Río Garma
Natalia García Sánchez
Inés Del Rio Pastoriza
José Manuel Fernández Bustillo
Miguel Fernández Rodríguez
María José Fernández Seara
Jorge Fernández Jiménez
Sacramento Garabal Sánchez
Carmen Losada Pazo
Patricia Miguez Sánchez
Josefina Pena Nieto
Inmaculada Pérez Castro
Pilar Pereira García
Cristina Pérez Del Olmo
Matilde Sagrario Somoza Martín
Ángel López-Silvarrey Varela
Collaborating sub-investigators Neumology: José Javier González Barcala
Carlos Magan
José Domingo Moure Gónzalez
Carlos García Magán
Collaborating sub-investigators Traumatology José Ramón Caeiro Rey
Alberto Diez Ulloa
Carlos Pernal Durán
Jesús Pino Miguéz
María Otero Fernández
Collaborating sub-investigators Neonatal Mª Luz Couce Pico
Mª José Fernández Seara
Alicia Iglesias Deus
Collaborating sub-investigators Microbiology Gema Barbeito Castiñeiras
Marisa Pérez del Molino
Collaborating sub-investigators Otorrino Antonio Lirola Delgado
María del Rio Valeiras
Collaborating sub-investigators Cardiology Bernardo López Abel
Research Nurses Nuria Calviño Vieito
Luisa García Vicente
Mª Pilar Leboráns Iglesias
Lidia Piñeiro Rodríguez
Sara Rey Vázquez
Miguel Sadiki Orayyou
Sonia Serén Fernández
María Soledad Vilas Iglesias
Data Management Carmen Rodríguez-Tenreiro Sánchez
Rita Soler Martín
Managment María Barreiro Casto
Sandra Carnota Antonio
Belén Mosquera Pérez
Cristina Serén Trasorras

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)

Protocol number

6096A1-501

Phase:

3

Promoter:

Wyeth

Current Status:

Closed

 

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 number

6096A1-3007

Phase:

3

Promoter:

Wyeth

Current Status:

Closed

 

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 number:

MRV01C

Phase:

3

Promoter:

Sanofi Pasteur MSD

Current Status:

Closed

 

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 number:

V72P12

Phase:

2b

Promoter:

Novartis

Current Status:

Closed

 

A Single blind, Randomized Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants

Protocol number:

6108K2-2000-ES

Phase:

1-2

Promoter:

Wyeth

Current Status:

Closed

 

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 number:

MI-CP178

Phase:

1-2

Promoter:

Medimmune

Current Status:

Closed

 

A Single blind, Randomized Phase 2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine at dose of 60 g, 120 g y 200 g in Healthy Adolescentes aged 11 to 18 years

Protocol number:

6108A1-2001-WW

Phase:

1-2

Promoter:

Medimmune

Current Status:

Closed

 

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 V72P12

Protocol number:

V72P12E1

Phase:

2b

Promoter:

Novartis

Current Status:

Closed

 

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 number:

6096A1-4001-EU

 

Phase:

4

 

Promoter:

Pfizer

 

Current Status:

Closed

 

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 number:

V114-003

Phase:

2

Promoter:

Merck Sharp & Dohme Corp

Current Status:

Closed

 

A phase IIa, observer-blind, multi-country, multicentre, randomised study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals' quadrivalent influenza vaccine (QIV) adjuvanted with various doses of the AS03 (GSK2584786A), administered in children aged 6 to 35 months, and compared to non-adjuvanted QIV

Protocol number:

114294 (FLUD-QIV-AS03-005)

Phase:

2a

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Cancelled

 

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 number:

WP22849

Phase:

1

Promoter:

Roche

Current Status:

Closed

 

A phase III, observer-blind, randomized, multi-country, 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 number:

115345 (FLU D-QIV-004 PRI)

Phase:

3

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Closed

 

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-old)

Protocol number:

GDS01C

Phase:

2

Promoter:

Sanofi Pasteur MSD S.N.C.

Current Status:

Closed

 

A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety,Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant VaccineWhen Administered Alone to Healthy Infants According to Different ImmunizationSchedules and to Healthy Children aged 2 to 10 Years

Protocol number:

V72_28

Phase:

3

Promoter:

Novartis

Current Status:

Closed

 

Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345

Protocol number:

11602 (-FLU-D-QIV—09 EXT004)

Phase:

3

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Closed

 

Immunogenicity and Safety Study of GSK Biologicals' Priorix® Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life

Protocol number:

115649 (MMR-161)

Phase:

2a

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Closed

 

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 number:

PRI02C

Phase:

3

Promoter:

Sanofi Pasteur MSD

Current Status:

Closed

 

A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™

Protocol number:

V260-035

Phase:

3

Promoter:

Merck Sharp & Dohme Corp

Current Status:

Closed

 

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 number:

V72_28E1

Phase:

3b

Promoter:

Novartis

Current Status:

Closed

 

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

Protocol number:

V72P12E2

Phase:

3

Promoter:

Novartis

Current Status:

Closed

 

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 number:

A3L39

Phase:

3

Promoter:

Sanofi Pasteur SA

Current Status:

Closed

 

A 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.

Protocol number:

V72_62

Phase:

3

Promoter:

Novartis

Current Status:

Closed

 

A Phase IIIb, open-label, multi-centric study to evaluate the immunogenicity of one dose of GSK Biologicals´ MenACWY-TT conjugate vaccine administered intramuscularly in healthy adolescents aged 10 to 15 years, previously primed with a MenC conjugate vaccine

Protocol number:

116775 (MENACWY-TT-089)

Phase:

3b

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Cancelled

 

Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children

Protocol number:

201251 (FLUD-QIV-015)

Phase:

3

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Closed

 

Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months.

Protocol number:

GQM05

 

Phase:

3

 

Promoter:

Sanofi Pasteur MSD

 

Current Status:

Closed

 

 

A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DaptomycinVersus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms

Protocol number:

DAP-PEDOST-11-03

Phase:

3

Promoter:

CubistPharmaceuticals

Current Status:

Closed

 

A Phase I/IIMulticentre 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 number:

ALX0171-C104

Phase:

1/2

Promoter:

Ablynx NV

Current Status:

Closed

 

A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an AdjuvantedQuadrivalent Subunit Influenza Virus Vaccine Compared to Non- Adjuvanted Trivalent Inactivated Influenza Vaccine in Children 6 to < 72 Months of Age.

Protocol number:

V118-05

Phase:

3

Promoter:

Novartis

Current Status:

Closed

 

Evaluación del papel inmunoregulador de la vacunación conjugada antineumocócica en pacientes pediátricos con asma alérgica o diabetes mellitus tipo 1 verus población pediátrica control.

Protocol number:

PNEUMOREG

Phase:

4

Promoter:

Federico Martinón Torres

Current Status:

Ongoing

 

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 number:

A3L40

Phase:

3

Promoter:

Sanofi Pasteur MSD

Current Status:

Closed

 

A double blind, randomized, stratified, multi-center trial evaluating conventional and double dose oseltamivir in the treatment of immunocompromised patients with influenza

Protocol number:

NV20234/C

Phase:

3

Promoter:

Hoffmann-La Roche

Current Status:

Closed

 

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 number:

BP27832

Phase:

2

Promoter:

Hoffmann-La Roche

Current Status:

Closed

 

A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a human Monoclonal antibody, REGN2222, for the prevention of medically attended rsv infection in preterm infants

Protocol number:

R2222-RSV-1332

Phase:

3

Promoter:

RegeneronPharmaceuticals

Current Status:

Closed

 

Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women

Protocol number:

116945 [DTPA (Boostríx)-047]

Phase:

4

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Closed

 

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection.

Protocol number:

53718678RSV1005

Phase:

1b

Promoter:

Janssen Research & Development

Current Status:

Closed

 

Protocol number:

 

Phase:

 

Promoter:

 

Current Status:

 

 

A phase IV, open-label, non-randomised, multicentre study to assess the immunogenicity and safety of Infanrix hexa™ administered as primary vaccination in healthy infants born to mothers vaccinated with Boostrix™ during pregnancy or immediately post-delivery.

Protocol number:

201330 [DTPA (BOOSTRIX)-048 PRI]

Phase:

4

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Closed

 

Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE

Protocol number:

ALIC4E

Phase:

4

Promoter:

Oxford University

Current Status:

Ongoing

 

Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Infanrix Hexa™ (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

Protocol number:

201334  [DTPA (BOOSTRIX)-049 BST: 048]

Phase:

4

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Closed

 

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study To Evaluate The Safety And Efficacy Of Staphylococcus Aureus 4 Antigen Vaccine (sa4ag) In Adults Undergoing Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

Protocol number:

B3451002

Phase:

2b

Promoter:

Pfizer

Current Status:

Closed

 

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Subjects Hospitalized With Respiratory Syncytial Virus

Protocol number:

64041575RSV2003

Phase:

2b

Promoter:

Janssen Research & Development

Current Status:

Closed

 

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants

Protocol number:

RSV-M-301

Phase:

3

Promoter:

NOVAVAX

Current Status:

Ongoing

 

A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

Protocol number:

D5290C00003

Phase:

2b

Promoter:

MedImmune LLC

Current Status:

Closed

 

A Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study of ALX-0171 in Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Protocol number:

ALX0171-C201

Phase:

2b

Promoter:

Ablynx NV

Current Status:

Closed

 

A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Protocol number:

DUR001 306

Phase:

3

Promoter:

Durata Therapeutics International B.V.

Current Status:

Closed

 

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants

Protocol number:

204838 (RSV PED-002)

Phase:

1/2

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Ongoing

 

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age

Protocol number:

MET51

Phase:

3

Promoter:

Sanofi Pasteur Inc.

Current Status:

Closed

 

A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

Protocol number:

V114-008

Phase:

2

Promoter:

Merck Sharp & Dohme Corp.

Current Status:

Closed

 

A Phase I/II, randomised, observer-blind, controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers

Protocol number:

204810 (RSV F-004)

Phase:

1/2

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Cancelled

 

A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects With Complicated Intra-Abdominal Infection

Protocol number:

MK7625A-035

Phase:

2

Promoter:

Merck Sharp & Dohme Corp.

Current Status:

Closed

 

A Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s Candidate Quadrivalent Influenza Vaccine

Protocol number:

INFQ3003

Phase:

3

Promoter:

Abbott Biologicasl B.V.

Current Status:

Ongoing

 

A Phase III/IV, Stratified, Randomized, Observer Blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Influenza Comparator Vaccine in Subjects 2 to <18 Years of Age

Protocol number:

V130_12

Phase:

3/4

Promoter:

Seqirus UK Ltd.

Current Status:

Ongoing

 

Prospective Study to Assess the Performance of Digital Health Technologies (Mobile App and Wearable, Wireless Biosensor Devices) to Monitor Changes in Respiratory Syncytial Virus Disease Severity in Children up to 2 Years of Age

Protocol number:

NOPRODRSV0010

Phase:

Not applicable

Promoter:

Janssen Research & Development

Current Status:

 

 

A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-hospitalized Adult Subjects Infected With Respiratory Syncytial Virus

Protocol number:

53718678RSV2004

Phase:

2

Promoter:

Janssen Research & Development

Current Status:

Ongoing

 

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

Protocol number:

64041575RSV2004

Phase:

2

Promoter:

Janssen Research & Development

Current Status:

Closed

 

A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children with a History of Respiratory Syncytial Virus Infection

Protocol number:

64041575RSV2002

Phase:

2

Promoter:

Janssen Research & Development

Current Status:

Cancelled

 

Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age

Protocol number:

V160-002

Phase:

2b

Promoter:

Merck Sharp & Dohme Corp.

Current Status:

Ongoing

 

A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants

Protocol number:

MK-1654-002

Phase:

1/2

Promoter:

Merck Sharp & Dohme Corp.

Current Status:

Ongoing

 

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus

Protocol number:

64041575MPN2001

Phase:

2b

Promoter:

Janssen Research & Development

Current Status:

Cancelled

 

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

Protocol number:

63623872FLZ3001

Phase:

3

Promoter:

Janssen Research & Development

Current Status:

Ongoing

 

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications

Protocol number:

63623872FLZ3002

Phase:

3

Promoter:

Janssen Research & Development

Current Status:

Ongoing

 

A Phase 2a Open-label Study in Infants with REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521

Protocol number:

REVC003

Phase:

2a

Promoter:

ReViral Ltd

Current Status:

Start-up

 

A multicenter, randomized, double-blind,Active (oseltamivir)-controlled study toAssess the safety, pharmacokinetics, andEfficacy of baloxavir marboxil in otherwiseHealthy pediatric patients 1 to <12 years ofAge with influenza-like symptoms

Protocol number:

CP40563

Phase:

3

Promoter:

F. Hoffmann-La Roche Ltd

Current Status:

Closed

 

A Phase III, partially modified, double-blind, randomized, parallel-group, active-controlled, multi-center study to compare the immunogenicity and describe the safety ao MenACYW conjugate vaccine and Nimenrix ®when administered as a three-dose series concomitantly with routine pediatric vaccines to healthy infants and toddlers

Protocol number:

MET58

Phase:

3

Promoter:

Sanofi Pasteur Inc.

Current Status:

Ongoing

 

Phase II, double-blind, placebo-controlled study to evaluate antiviral activity, clinical outcomes, safety, tolerability And the relationships between pharmacokinetics and pharmacodynamics of different doses of JNJ-53718678 in children  > 28 days and < 3 years of age with acute respiratory infection due to respiratory syncytial virus infection.

Protocol number:

53718678RSV2002

Phase:

2

Promoter:

Janssen Research & Development

Current Status:

Ongoing

 

Study to evaluate the safety, reactogenicity and immunogenicity of the experimental vaccine against the respiratory syncytial virus (VRS) of GSK Biologicals Based on viral proteins encoded by a chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in infants.

Protocol number:

204894 (RSV PED-011)

Phase:

1/2

Promoter:

GlaxoSmithKline Biologicals

Current Status:

Ongoing

 

Trial in Phase 1/2a, randomized, blind Observer, controlled, to evaluate the safety, reactogenicity and immunogenicity of Ad26,RSV,preF In seronegative children for respiratory syncytial Virus from 12 to 24 months of age.

Protocol number:

VAC18194RSV2002

Phase:

1/2

Promoter:

Janssen Research & Development

Current Status:

Ongoing

 

Estudio de fase 3, multicéntrico, aleatorizado, doble ciego y controlado con un fármaco de comparación activo para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de V114 en lactantes sanos (PNEU-PED-EU-1)

Protocol number:

V114-025

Phase:

3

Promoter:

Merck Sharp & Dohme Corp.

Current Status:

Ongoing


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