Pfizer begins phase 3 clinical trials of 20vPnC, RSVpreF, and MenABCWY vaccine candidates
US pharma giant Pfizer has initiated four phase 3 clinical trials within its present pipeline of investigational vaccines.
The company’s 20vPnC, which is a 20-valent pneumococcal polysaccharide conjugate vaccine candidate, will be evaluated in two phase 3 trials NCT04382326 and NCT04379713. Both the late-stage trials will evaluate a four-dose series in infants starting at the age of two months.
According to Pfizer, the studies will expand the data on the safety and tolerability of 20vPnC in infants. The two phase 3 clinical trials will have a control group of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).
The NCT04382326 trial will aim at determining immunologic noninferiority between 20vPnC and Prevnar 13, which is a vital requirement for vaccine licensure, as per Pfizer.
The US pharma giant has launched the NCT04424316 phase 3 clinical trial of RSVpreF, its respiratory syncytial virus (RSV) vaccine candidate in pregnant women. The late-stage trial will assess the safety and efficacy of the vaccine candidate in infants born to immunized pregnant women in comparison to placebo.
The fourth clinical trial initiated by Pfizer, which is NCT04440163, will be of MenABCWY, a pentavalent meningococcal vaccine candidate, in adolescents and young adults. The late-stage trial will assess the safety, tolerability, and immunogenicity of the MenABCWY vaccine candidate in comparison to licensed meningococcal vaccines, with an aim to determine immunologic noninferiority.
Kathrin U. Jansen – Pfizer Senior Vice President and Head of Vaccine Research & Development said: “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 unlock the potential promise and value that vaccines hold for our world.
“If approved, all three vaccine candidates could help prevent serious, possibly deadly infectious diseases that negatively impact millions of people of all ages globally.”