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Pfizer Starts Four Phase 3 Trials For Investigational Vaccines

Pfizer Inc. (PFE) said that it has initiated 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(r) (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).

Study NCT04382326 has the goal of determining immunologic noninferiority between 20vPnC and Prevnar 13(r), 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 mmunogenicity of the MenABCWY vaccine candidate compared to licensed meningococcal vaccines, with the goal of determining immunologic noninferiority.

About 20vPnC PediatricApproximately 3,500 infants will be enrolled in total for these two studies. In both studies, infants will be vaccinated with either 20vPnC or Prevnar 13(r) (13vPnC) at 2, 4, 6, and 12-15 months of age, along with other routine infant vaccines according to the current CDC recommended schedule.

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