Pfizer announces start of four phase 3 clinical trials for investigational vaccines

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 unlock 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.”

About 20vPnC Pediatric
Approximately 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^® (13vPnC) at 2, 4, 6, and 12-15 months of age, along with other routine infant vaccines according to the current CDC recommended schedule. Additional information can be found at www.clinicaltrials.gov under the identifiers NCT04382326 and NCT04379713. The results of the descriptive Phase 2 infant study with 20vPnC (NCT03512288) have been submitted for presentation at ID Week 2020.

In May 2017 the FDA granted Fast Track status for a pediatric indication for 20vPnC.

Global Burden of Pneumococcal Disease
Pfizer’s 20vPnC vaccine candidate includes 13 serotypes already included in Prevnar 13^® (13vPnC). Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally.

About RSVpreF
The Phase 3 trial of RSVpreF is a global, double-blind, placebo-controlled study that will enroll 6,900 pregnant women ages 18 through 49 and their infants. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04424316.

In April 2020, positive top-line results were achieved for a Phase 2b proof-of-concept study of RSVpreF, which evaluated the safety, tolerability and immunogenicity of RSVpreF in vaccinated pregnant women ages 18 through 49 and their infants. Detailed results from the study will be shared at a future medical conference. In November 2018, the FDA granted Fast Track status to RSVpreF for prevention of RSV-associated lower respiratory tract illness in infants by active immunization of pregnant women.

Global Burden of RSV
RSV is a virus that can cause severe respiratory disease in infants and older adults.^9,10 Globally, there are an estimated 33 million cases of RSV annually in children less than 5 years of age, with about 3 million hospitalized and approximately 120,000 dying each year from complications associated with the infection. Nearly half of these pediatric hospitalizations and deaths occur in infants less than 6 months of age. The medical community is limited to offering only supportive care for those with the illness.

AboutMenABCWY
The Phase 3 trial will enroll approximately 2,413 adolescents and young adults (10 through 25 years of age) from the United States and Europe. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04440163.

Initiation of the Phase 3 trial is based on positive results from a proof-of-concept study (NCT03135834) in 543 adolescents and young adults. Detailed results from the proof-of-concept study have been submitted for presentation at ID Week 2020.

Pfizer’s pentavalent meningococcal vaccine candidate combines its two approved meningococcal vaccines, Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) and Trumenba^® (meningococcal group B vaccine). Approvals of Nimenrix™ and Trumenba^® vary by country.

Global Burden of Meningococcal Disease
Meningococcal disease is an uncommon but serious disease that can attack without warning and lead to meningitis and serious blood infections. The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis groups (A, B, C, W and Y).Together, these meningococcal groups account for 96% of all invasive meningococcal disease (IMD), with group B accounting for the majority of disease in adolescents and young adults in the U.S. and Europe.

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