Ensayos Clínicos
Ensayos Clínicos tanto en el ámbito nacional como europeo realizados por los distintos grupos de investigación del Servicio de Pediatría del Hospital Clinico Universitario de Santiago
1 - Grupo GENVIP (Genética, Vacunas, Infecciones y Pediatría)
Código de protocolo: 6096A1-501. Fase: III
• 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
Código de protocolo: 6096A1-3007. Fase: III
• 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.
Código de protocolo: MRV01C. Fase: III
• 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
Código de protocolo: V72P12. Fase: II
• A Single blind, Randomized Phase 1/2 Trial of the Safety, Tolerability, and Immunogenicity of Meningococcal Group B rLP2086 Vaccine in Healthy Infants.
Código de protocolo: 6108K-2000-ES. Fase: I
• 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. Código de protocolo: MI-CP178. Fase: I • A 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 Adolescentes aged 11 to 18 years Código de protocolo: 6108A1-2001-WW. Fase II • 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 V72P12 Código de protocolo: V72P12E1. Fase:II • 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 Código de protocolo: 6096A1-4001-EU. Fase: IV • 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 Código de protocolo: V114-003. Fase: II • 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 and Código de protocolo: 114294 (FLUD-QIV-AS03-005). Fase: IIa • 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 Código de protocolo: WP22849. Fase: I • 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 Código de protocolo: 115345 (FLU D-QIV-004 PRI)Fase: III • 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) Código de protocolo: GDS01C. Fase: II • 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 Código de protocolo: V72_28. Fase: III • Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345 Código de protocolo: 11602 (-FLU-D-QIV—09 EXT004). Fase:III • 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 Código de protocolo: 115649 (MMR-161). Fase: IIA • 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. Código de protocolo: PRI02C. Fase: III • A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™ Código de protocolo: V260-035. Fase: III • 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. Código de protocolo: V72_28E1. Fase: IIIb • 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 Código de protocolo: V72P12E2. Fase: III • 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 Código de protocolo: A3L39. Fase: III • 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. Código de protocolo: V72_62. Fase: III • 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 Código de protocolo: 116775 (MENACWY-TT-089). Fase: IIIb • Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children Código de protocolo: 201251 (FLUD-QIV-015). Fase: III • Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months. Código de protocolo: GQM05. Fase: III • 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 Código de protocolo:DAP-PEDOST-11-03 • A Phase I/IIMulticentre Study in Otherwise Healthy Infants and Toddlers HospitalisedFor 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. Código de protocolo: ALX0171-C104. Fase: I/II • 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. Código de protocolo: V118-05. Fase: III • Evaluación del papel inmunoregulador de la vacunación conjugada antineumocócica en pacientes pediátricos con asma alérgica o diabetes mellitus tipo 1 verus población pediátrica control. Código: PNEUMOREG. Fase: IV • 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. Código de protocolo:A3L40. Fase: • A double blind, randomized, stratified, multi-center trial evaluating conventional and double dose oseltamivir in the treatment of immunocompromised patients with influenza. Código de protocolo:NV20234/C • 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). Código de protocolo: BP27832. Fase: II • 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 Código de protocolo: R2222-RSV-1332. Fase: III • Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women Código de protocolo: 116945 [DTPA (Boostríx)-047]. Fase: IV • 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. Código de protocolo: 53718678RSV1005. Fase Ib • 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. Código de protocolo:201330 [DTPA (BOOSTRIX)-048 PRI]. Fase: IV • Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE Código de protocolo: ALIC4E. Fase: IV • 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 Código de protocolo:201334 [DTPA (BOOSTRIX)-049 BST: 048]. Fase: IV • 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 Código de protocolo: B3451002. Fase: IIb • 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 Código de protocolo: 64041575RSV2003. Fase: IIb • 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 Código de protocolo:RSV-M-301. Fase: III • 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 Código de protocolo:D5290C00003. Fase: IIb • 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 Código de protocolo: ALX0171-C201. Fase: IIb • 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 Código de protocolo: DUR001 306. Fase: III • 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 Código de protocolo: 204838 (RSV PED-002). Fase: I/II • Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age Código de protocolo: MET51. Fase: III • A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants Código de protocolo: V114-008. Fase: II • 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 Código de protocolo: 204810 (RSV F-004). Fase: I/II • 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 Código de protocolo: MK7625A-035. Fase: II • 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 Código de protocolo: INFQ3003. Fase: III • 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 Código de protocolo: V130_12. Fase: III/IV • 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 Código de protocolo: NOPRODRSV0010 • 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 Código de protocolo: 53718678RSV2004. Fase: II • 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 Código de protocolo: 64041575RSV2004. Fase: II • 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 Código de protocolo: 64041575RSV2002. Fase: II • 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 Código de protocolo: V160-002. Fase: IIb • 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 Código de protocolo: MK-1654-002. Fase: I/II • 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 Código de protocolo: 64041575MPN2001. Fase: IIb • 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 Código de protocolo: 63623872FLZ3001. Fase: III • 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 Código de protocolo: 63623872FLZ3002. Fase: III • 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 Código de protocolo: REVC003. Fase: IIa • A multicenter, randomized, double-blind,Active (oseltamivir)-controlled study toAssess the safety, pharmacokinetics, andEfficacy of baloxavirmarboxil in otherwiseHealthy pediatric patients 1 to <12 years ofAge with influenza-like symptoms Código de protocolo: CP40563. Fase: III • A Phase III, partially modified, double-blind, randomized, parallel-group, active-controlled, multi-center study to compare the immunogenicity and describe the safety aoMenACYW conjugate vaccine and Nimenrix ®when administered as a three-dose series concomitantly with routine pediatric vaccines to healthy infants and toddlers Código de protocolo: MET5. Fase: III • 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. Código de protocolo: 53718678RSV2002. Fase: II • 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. Código de protocolo: 204894 (RSV PED-011). Fase: I/II • 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. Código de protocolo: VAC18194RSV2002. Fase: I/II • 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) Código de protocolo: V114-025. Fase: III • Estudio en fase III aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad y la eficacia de MEDI8897, un anticuerpo monoclonal con una semivida prolongada frente al virus respiratorio Código de protocolo: D5290C00004. Fase: III • Estudio en fase II/III aleatorizado, doble ciego, controlado con palivizumab para evaluar la seguridad de MEDI8897, un anticuerpo monoclonal con una semivida prolongada frente al virus respiratorio Código de protocolo: D5290C00005. Fase: III • Estudio abierto, multicéntrico y de un solo grupo para evaluar la seguridad, la farmacocinética y la eficacia de BaloxavirMarboxil en pacientes pediátricos con síntomas seudogripales y por lo demás sanos desde el nacimiento hasta menos de 1 año. Código de protocolo: CP40559. Fase: III • A phase 3, randomized, double- or observer-blinded, placebo-controlled trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefunsion F subunit vaccine in infants born to women vaccinated during pregnancy. Código de protocolo: C3671008. Fase: III • A phase 3, randomized, double-blind trial to evaluate the safety of a 20-valent pneumococcal conjugate vaccine in healthy infants Código de protocolo: B7471013. Fase: III • A phase 2b, open-label trial to assess the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age Código de protocolo: C3511002. Fase: IIb • A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Remdesivir (GS-5734) in Participants from Birth to < 18 Years of Age with COVID-19 Código de protocolo: GS-US-540-5823. Fase: II/ III • A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) Código de protocolo: 5371867RSV3001 (DAISY). Fase: III • Estudio de faseIIIbabierto para evaluar la seguridad e inmunogenicidad de Nimenrixenlactantessanos, administrado a los 3 y 12 meses de edad. Código de protocolo: C0921062. Fase: IIIb • A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive Código de protocolo: VAC31518COV2001. Fase: IIa • 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 (REVIRAL 1) Código de protocolo: REVC003 (REVIRAL). Fase: IIa • A phase IV, single-blind, randomised, controlled, multi-country study to evaluate the immunogenicity and safety of GSK’s Infanrix hexa (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV’s Vaxelis (DTaP5-HBV-IPV-Hib), when administered intramuscularly according to a 2-, 4- and 12-month schedule in healthy infants and toddlers Código de protocolo: 212645. Fase: IV • Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines with AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (two Monovalent and one Bivalent) Código de protocolo: VAT00002. Fase: I • A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blinded, Study to Evaluate to the Safety, Tolerability and Immunogenicity of SARS-CoV-2 RNA Vaccine Candidate (BNT162b2) against COVID-19 IN Healthy Pregnant Women 18 years of Age and Older Código de protocolo: C4591015. Fase: II-III • A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN AND ADOLESCENTS ≥5 TO <18 YEARS OF AGE Código de protocolo: C4591007. Fase: I • Estudio de inmunogenia y seguridad de unavacunaconjugadaantimeningocócicatetravalente con respecto a Nimenrix®, y cuando se administra sola o de maneraconcomitante con las vacunas 9vHPV y Tdap-IPV enadolescentessanos Código de protocolo: MEQ00071. Fase: I • A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease Código de protocolo: MK1654-007. Fase: III • A Phase III, observer-blind, randomized, multi-country study to evaluate the lot-to-lot consistency of GSK’s investigational RSV maternal vaccine and the immune response, safety and reactogenicity of RSV maternal vaccine when co-administered with GSK’s quadrivalent influenza D-QIV vaccine in healthy non-pregnant women 18-49 years of age. Código de protocolo: RSV MAT-010. Fase: III • A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and above. Código de protocolo: RSV OA=ADJ-006. Fase: III • Estudio de fase II, aleatorizado y parcialmenteciego, para evaluar la seguridad, reactogenicidad e inmunogenicidad de la vacunaantimeningocócicacombinada ABCWY trassuadministraciónenlactantessanos. Código de protocolo: 217043 (MENACWY=MEN7B-003). Fase: II • A Phase 2, randomized, double-blind, placebo-controlled, 2-part study to evaluate edp-938 regimens in subjects aged 28 days to 36 months infected with respiratory syncytial virus (RSV) Código de protocolo: EDP 938-201. Fase: II[/et_pb_accordion_item][et_pb_accordion_item title="2 - Grupo METABOLOPATÍAS" _builder_version="3.12.2" border_radii="on|0px|0px|0px|0px" global_colors_info="{}" open="off"]
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4 - Grupo SOPORTE VITAL Y SIMULACIÓN MÉDICA
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