Unidad de Ensayos clínicos de Vacunas Fundación HM 

 

 

 2021- on going GSK / IP  

A phase II, randomized, observer-blinded, controlled, multicenter trial to evaluate safety, reactogenicity, efficacy, and immunogenicity of GSK Biologicals' respiratory syncytial virus (RSV) investigational vaccine when administered intramuscularly according to a 2-dose schedule to infants aged 3 to 7 months at first intervention administration. 



2021-Pfizer/IP  

Phase 1/2/3 Pediatric SARS-CoV-2 RNA Vaccine study. The primary objective of the study is to evaluate up to 3 dose levels of BNT162b2 (10 μg, 20 μg, 30 μg) for safety, tolerability, and immunogenicity in healthy children to <18 years of age. 



2021-Janssen /IP  

Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S COVID19 in Healthy Pregnant Participants 

 

2021-Pfizer/IP  

Phase 2/3 COVID-19 vaccine clinical trial. The primary objective of the C4591015 study is to describe the safety, tolerability and immunogenicity of SARS-CoV-2 RNA vaccine candidate (BNT162b2) against in healthy pregnant women 18 years or older. 

 

2021-ongoing Janssen / IP 

A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity  of Different Dose Levels of Ad26.COV2.S COVID19 Administered as a Single-dose or Two-dose Regimen in Children Aged 2 Months to 18 Years Inclusive and to Evaluate One Dose Level of Ad26.COV2.S Administered as a Two- dose Regimen in Healthy Adults Aged 18 to 55 Years Inclusive  

 

2021- on going Pfizer / IP   

A Phase 2 Open-Label Trial To Assess The Safety, Tolerability, and Immunogenicity of MenABCWY in Healthy Infants 2 and 6 months of Age 

 

2020- ongoing Janssen / IP  

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-53718678 in Infants and Children (≥28 Days to ≤3 Years of Age) and Subsequently Including Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) Infection 

 

2020-on going Pfizer /IP 

A Phase 3, Randomized, Double- Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and safety of a  Respiratory Syncitial Virus (RSV) Prefusion F Subunit Vaccine in  Infants Born to Women Vaccinated during Pregnancy -C3671008-. 

 

2019-on going AstraZeneca / IP

A Phase 3 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 Late Preterm and Term Infants. Melody. 

 

2018- ongoing Janssen / IP 

Estudio en fase II, doble ciego y controlado con placebo para evaluar la actividad antiviral, los resultados clínicos, la seguridad, la tolerabilidad y las relaciones entre farmacocinética y farmacodinámica de dosis diferentes de JNJ-53718678 en niños ≥28 días y ≤3 años de edad con infección respiratoria aguda debido a la infección por el virus respiratorio sincitial.  

53718678RSV2002