PF-06425090 / Pfizer - LARVOL DELTA

CLOVER: A Phase 3 Randomized Trial Investigating the Efficacy and Safety of a Detoxified Toxin A/B Vaccine in Adults 50 Years and Older at Increased Risk of Clostridioides difficile Infection. (PubMed, Clin Infect Dis) - P3 | "Three PF-06425090 doses were safe and well-tolerated. Although the primary endpoint was not met, PF-06425090 reduced symptom duration, CDI requiring medical attention, and CDI-directed antibiotic treatment, highlighting its potential to reduce CDI-associated healthcare burden. NCT03090191."

Journal • P3 data • Infectious Disease

Emerging Options for the Prevention and Management of Clostridioides difficile Infection. (PubMed, Drugs) - "These agents include one antibiotic (ridinilazole), three live biotherapeutic products (LBPs) (CP101, RBX2660, and SER109), and two toxoid vaccines (PF06425090 and a second toxoid vaccine). As new prevention and treatment strategies enter the market, clinicians and administrators will need knowledge of these products to make rational decisions on how best to adopt them into clinical practice."

Journal • Infectious Disease

Clover: Clostridium Difficile Vaccine Efficacy Trial (clinicaltrials.gov) - P3; N=17524; Completed; Sponsor: Pfizer; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years (clinicaltrials.gov) - P2; N=300; Completed; Sponsor: Pfizer; N=944 ➔ 300

Clinical • Enrollment change

Clover: Clostridium Difficile Vaccine Efficacy Trial (clinicaltrials.gov) - P3; N=17526; Active, not recruiting; Sponsor: Pfizer; Trial completion date: Feb 2021 ➔ Sep 2021; Trial primary completion date: Feb 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (clinicaltrials.gov) - P3; N=1998; Completed; Sponsor: Pfizer; Active, not recruiting ➔ Completed

Clinical • Trial completion

Clover: Clostridium Difficile Vaccine Efficacy Trial (clinicaltrials.gov) - P3; N=17526; Active, not recruiting; Sponsor: Pfizer; Trial completion date: Sep 2020 ➔ Feb 2021; Trial primary completion date: Sep 2020 ➔ Feb 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (clinicaltrials.gov) - P3; N=1998; Active, not recruiting; Sponsor: Pfizer; Trial primary completion date: Aug 2020 ➔ Dec 2020

Clinical • Trial primary completion date

[VIRTUAL] Immunogenicity, Safety and Tolerability of a Booster Dose of Clostridium difficile Vaccine and 4 Year Antibody Persistence (IDWeek 2020) - "A booster dose of Clostroidides difficile vaccine candidate is highly immunogenic, well tolerated and demonstrates an acceptable safety profile in both dose groups for the Day and the Month regimens. Antibody persistence remains stable from 12 months to 4-year post dose 3."

Clinical • Infectious Disease

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (clinicaltrials.gov) - P3; N=1998; Active, not recruiting; Sponsor: Pfizer; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years (clinicaltrials.gov) - P2; N=944; Completed; Sponsor: Pfizer; Active, not recruiting ➔ Completed

Clinical • Trial completion

Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age (clinicaltrials.gov) - P3; N=1316; Not yet recruiting; Sponsor: Pfizer

New P3 trial • Biosimilar

Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age (clinicaltrials.gov) - P3; N=1317; Completed; Sponsor: Pfizer; Recruiting ➔ Completed

Clinical • Trial completion

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (clinicaltrials.gov) - P3; N=1960; Recruiting; Sponsor: Pfizer; N=500 ➔ 1960

Clinical • Enrollment change

Clover: Clostridium Difficile Vaccine Efficacy Trial (clinicaltrials.gov) - P3; N=17454; Active, not recruiting; Sponsor: Pfizer; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (clinicaltrials.gov) - P3; N=500; Recruiting; Sponsor: Pfizer; Trial completion date: Aug 2020 ➔ Dec 2020; Trial primary completion date: Jan 2020 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (clinicaltrials.gov) - P3; N=500; Recruiting; Sponsor: Pfizer

Clinical • New P3 trial