Pfizer Launches Four Phase 3 Clinical Trials to Evaluate Three Investigational Vaccines: 20-Valent Pneumococcal, RSV, and Pentavalent Meningococcal Vaccines

June 24, 2020 News /BioonBIOON/ --Pfizer(Pfizer) recently announced the initiation of four Phase IIIClinical Trial, to evaluate multiple vaccines in its pipeline.

Two studies (NCT04382326 and NCT04379713) will be conducted in infants aged ≥2 months to evaluate the 4-dose immunization schedule of the 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC). These studies will expand the data on the safety and tolerability of 20vPnC in infants, and will include a Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) control group. Among them, the purpose of study NCT04382326 is to determine the differences between 20vPnC and Prevnar 13®.ImmunologyNon-inferiority is a key requirement for vaccine licensure.

One study (NCT04424316) will be conducted in pregnant women; this is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of maternal immunization with the respiratory syncytial virus (RSV) candidate vaccine RSVpreF for the prevention of lower respiratory illness (LRI) in infants.

One study (NCT04440163) will be conducted in adolescents and young adults to evaluate the safety, tolerability, and immunogenicity of the pentavalent meningococcal vaccine MenABCWY compared with licensed meningococcal vaccines, with the aim of determiningImmunologyNon-inferiority.

Dr. Kathrin U. Jansen, Senior Vice President and Head of Vaccines at Sanofi, stated: “The simultaneous initiation of four Phase III studies in the vaccine pipeline underscores Pfizer’s continued commitment to uncovering the potential promise and value of vaccines. If approved, all three candidate vaccines would help prevent serious, potentially life-threatening infectious diseases that adversely affect millions of people of different ages worldwide.”

——20vPnC：This is a 20-valent pneumococcal polysaccharide conjugate vaccine, which includes the 13 serotypes covered by Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as well as seven additional serotypes (8, 10A, 11A, 12F, 15BC, 22F, and 33F). These seven new serotypes are all global causes of invasive pneumococcal disease, with six of them (8, 10A, 11A, 15BC, 22F, and 33F) associated with high case-fatality rates, and four associated withAntibioticsdrug resistance (serotypes 11A, 15B/C, 22F, and 33F) and/or meningitis (serotypes 10A, 15B/C, 22F, and 33F). Previously, the U.S. FDA granted Breakthrough Therapy Designation (BTD) to 20vPnC for the prevention of invasive disease and pneumonia in adults aged 18 years and older. In September 2017 and May 2019,FDAIt also granted Fast Track Designation (FTD) for 20vPnC for adult and pediatric indications, respectively.

——RSVpreF：This is a candidate vaccine for respiratory syncytial virus (RSV), designed to enable infants to acquire protection against lower respiratory illness (LRI) through maternal immunization. In April this year, the Phase IIb proof-of-concept study yielded positive top-line results, with detailed findings to be presented at upcoming medical conferences.Meetingpublished above. In November 2018,FDAGranted Fast Track Designation (FTD) for RSVpreF to prevent infant RSV-associated lower respiratory tract disease through active immunization of pregnant women.

——MenABCWY：This is a pentavalent meningococcal vaccine that combines two approved meningococcal vaccines: Nimenrix (a conjugate vaccine against serogroups A, C, W-135, and Y) and Trumenba (a vaccine against serogroup B). Meningococcal disease is a rare but serious illness that can strike without warning, leading to meningitis and severe bloodstream infections. The majority of invasive meningococcal disease cases worldwide are attributable to five serogroups of Neisseria meningitidis (A, B, C, W, and Y). These five serogroups account for 96% of all invasive meningococcal disease (IMD) cases, with serogroup B responsible for the majority of cases among adolescents and young adults in the United States and Europe. (Bioon.com)

Original Source: Pfizer Announces Start of Four Phase 3 Clinical Trials for Investigational Vaccines