Pfizer starts Four Phase 3 Clinical Trials for Investigational Vaccines
New York: Pfizer Inc. has announced the initiation of four Phase 3 clinical trials within its current pipeline of investigational vaccines:
Two studies (NCT04382326 and NCT04379713) of the 20-valent pneumococcal polysaccharide conjugate vaccine candidate, 20vPnC, evaluating a four-dose series in infants starting at 2 months of age. Both studies will expand the data on the safety and tolerability of the investigational vaccine in infants and include a control group of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). Study NCT04382326 has the goal of determining immunologic noninferiority between 20vPnC and Prevnar 13, a critical requirement for vaccine licensure.
One study (NCT04424316) of the respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in pregnant women to evaluate the safety and efficacy of RSVpreF in infants born to immunized pregnant women as compared to placebo.
One study (NCT04440163) of the pentavalent meningococcal vaccine candidate, MenABCWY, in adolescents and young adults to assess the safety, tolerability, and immunogenicity of the MenABCWY vaccine candidate compared to licensed meningococcal vaccines, with the goal of determining immunologic noninferiority.
"The start of four Phase 3 studies across our portfolio of investigational vaccines is a testament to the talented and dedicated colleagues working throughout Pfizer, and the continued commitment to unlocking the potential promise and value that vaccines hold for our world," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc. "If approved, all three vaccine candidates could help prevent serious, possibly deadly infectious diseases that negatively impact millions of people of all ages globally."