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Pfizer Posts Positive Study Data In 20-Valent Pneumococcal Conjugate Vaccine In Infants In EU

Pfizer Inc. (PFE) announced Monday positive top-line results from its Phase 3 Study in 20-Valent pneumococcal conjugate vaccine candidate or 20vPnC in infants in the European Union.

The Phase 3 study (NCT04546425) in infants evaluated its 20vPnC for the prevention of invasive pneumococcal disease or IPD, pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.

The study had three coprimary outcomes, associated with immunogenicity responses one month after the second and third doses of a three-dose vaccination series given at approximately 2, 4, and 11-12 months of age of 20vPnC compared to Prevenar 13.

The company noted that all 20 serotypes showed increased booster responses from post dose 2 to post dose 3 which are indicative of immunological memory and long-term protection. All 20 vaccine serotypes also showed strong functional antibody responses.

According to the company, the totality of positive 20vPnC data, combined with the experience with Prevenar 13 in this schedule, demonstrates that the 20vPnC candidate, if approved, would help protect against all 20 vaccine serotypes in a three-dose vaccine series.

Pfizer said it plans to file these data with the European Medicines Agency by the end of this year. The company will also seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed.

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