VAX-31 / Vaxcyte - LARVOL DELTA

Safety, tolerability, and immunogenicity of a 31-valent pneumococcal conjugate vaccine (VAX-31) in healthy adults aged 50 years and older from the USA: a phase 1/2, double-blinded, active-controlled, parallel-group, dose-finding randomised clinical trial. (PubMed, Lancet Infect Dis) - P1/2 | "Across all doses, VAX-31 was well tolerated, had a safety profile similar to PCV20, and elicited robust OPA responses across all 31 serotypes. These data further validate the potential for VAX-31 to provide broad-spectrum coverage with high immunogenicity to protect against circulating and historically prevalent serotypes and, if confirmed in phase 3 studies, to have important public health and vaccination policy implications."

Journal • P1/2 data • Infectious Disease • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination (clinicaltrials.gov) - P3 | N=720 | Recruiting | Sponsor: Vaxcyte, Inc.

New P3 trial • Infectious Disease • Pneumococcal Infections

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants (clinicaltrials.gov) - P2 | N=905 | Active, not recruiting | Sponsor: Vaxcyte, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pediatrics • Pneumococcal Infections

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age (clinicaltrials.gov) - P3 | N=1300 | Recruiting | Sponsor: Vaxcyte, Inc.

New P3 trial • Infectious Disease • Influenza • Pneumococcal Infections • Respiratory Diseases

Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49 (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: Vaxcyte, Inc.

New P3 trial • Infectious Disease • Pneumococcal Infections

Response to Anticipated impact of novel adult-specific pneumococcal conjugate vaccine by Joshi et al. (PubMed, Vaccine) - No abstract available

Journal • Infectious Disease • Pneumococcal Infections

Application of Network Meta-Analysis in Vaccine Research: An Illustration Using Immunogenicity of Pneumococcal Vaccines in Adults (ISPOR-EU 2025) - "OBJECTIVES: A frequentist network meta-analysis (NMA) using data from clinical trials on pneumococcal vaccines (PnVx; licensed/under development) for adult (aged ≥50 years) immunisation was conducted to provide an overview of PnVx's immunogenicity performance against serotype 3 (ST3), associated with substantial disease burden in Europe. An NMA was performed to describe the immunogenicity of PnVx in terms of opsonophagocytic activity (functional) titres against ST3 including immunogenicity data on 8 PnVx (pneumococcal conjugate vaccines [PCV20, PCV13, PCV15, V116, Vax-24, Vax-31], 23-valent pneumococcal polysaccharide vaccine [PPSV23], and 24-valent MAPS technology-based PnVx [Pn-MAPS24v]) evaluated in 9 trials (phase 1/2, phase 2, and phase 3). The application of NMA in vaccine research may provide considerable benefit to researchers and decision-makers by supporting a detailed understanding of the relative immunogenicity induced by different vaccines, integrating..."

Pneumococcal vaccines • Retrospective data • Infectious Disease • Pneumococcal Infections • Pneumonia

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants (clinicaltrials.gov) - P2 | N=900 | Recruiting | Sponsor: Vaxcyte, Inc. | Trial completion date: Jun 2027 ➔ Dec 2027 | Trial primary completion date: Jun 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • Infectious Disease • Pediatrics • Pneumococcal Infections

Safety, tolerability, and immunogenicity of 31-valent pneumococcal conjugate vaccine (VAX-31) in healthy adults =50 years: a Phase 1/2, randomised, active-controlled, dose-finding study (ESCMID Global 2025) - No abstract available

Clinical • P1/2 data • Infectious Disease • Pneumococcal Infections

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: Vaxcyte, Inc.

New P2 trial • Infectious Disease • Pediatrics • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults (clinicaltrials.gov) - P1/2 | N=1015 | Completed | Sponsor: Vaxcyte, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults (clinicaltrials.gov) - P1/2 | N=1015 | Active, not recruiting | Sponsor: Vaxcyte, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pneumococcal Infections