GSK5101955 / GSK - LARVOL DELTA

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=388 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ Sep 2025 | Trial primary completion date: Jul 2026 ➔ Sep 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=472 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=121 ➔ 472

Enrollment change • Enrollment closed • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=121 | Recruiting | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=121 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Apr 2025 ➔ Jul 2026 | Trial primary completion date: Oct 2024 ➔ Jul 2026

Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=121 | Active, not recruiting | Sponsor: Affinivax, Inc. | Recruiting ➔ Active, not recruiting | N=760 ➔ 121

Enrollment change • Enrollment closed • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=760 | Recruiting | Sponsor: Affinivax, Inc. | N=472 ➔ 760 | Trial completion date: Nov 2023 ➔ Apr 2025 | Trial primary completion date: Aug 2023 ➔ Oct 2024

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=472 | Recruiting | Sponsor: Affinivax, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years. (PubMed, Vaccine) - P1/2 | "These results demonstrate that ASP3772 is well tolerated, highly immunogenic, and in adults may offer significantly broader protection than existing pneumococcal vaccines."

Journal • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain • Pneumococcal Infections • Pneumonia

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants (clinicaltrials.gov) - P2 | N=472 | Not yet recruiting | Sponsor: Affinivax, Inc.

New P2 trial • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator (clinicaltrials.gov) - P1 | N=75 | Completed | Sponsor: Affinivax, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pneumococcal Infections

"Shortly after Astellas steps aside, @GSK agrees $3.3bn deal to acquire @Affinivax and its pneumococcal vaccine ASP3772, a potential rival to @Pfizer's big-selling Prevnar family https://t.co/GXV3XEfLPN" (@pharmaphorum)

Clinical • Infectious Disease • Pneumococcal Infections

A Pneumococcal Vaccine Study A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator (clinicaltrialsregister.eu) - P1; N=75; Sponsor: Astellas Pharma Global Development Inc.

Clinical • New P1 trial • Dermatology • Infectious Disease • Pneumococcal Infections

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator (clinicaltrials.gov) - P1; N=75; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Pneumococcal Infections

[VIRTUAL] Safety and immunogenicity of ASP3772, a novel 24-valent pneumococcal vaccine, in elderly participants (ECCMID 2021) - "The novel ASP3772 multivalent pneumococcal vaccine was safe, well tolerated, and exhibited robust immunogenicity that extended beyond serotypes shared with PCV13 in elderly adults aged 65-85 years."

Clinical • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain • Pneumococcal Infections • Pneumonia

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator (clinicaltrials.gov) - P1; N=75; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Sep 2021 ➔ Mar 2022; Trial primary completion date: Sep 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease

Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects (clinicaltrials.gov) - P1; N=126; Completed; Sponsor: Astellas Pharma Inc; Active, not recruiting ➔ Completed; Trial completion date: Mar 2021 ➔ Nov 2020; Trial primary completion date: Mar 2021 ➔ Nov 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date

A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine (clinicaltrials.gov) - P1/2; N=630; Completed; Sponsor: Astellas Pharma Global Development, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

[VIRTUAL] Safety and Immunogenicity of Novel 24-Valent Pneumococcal Vaccine in Healthy Adults (IDWeek 2020) - " Healthy adults aged 18-64 years were randomized into this active-controlled, observer-blinded, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of ASP3772 at three dose levels compared to Prevnar13 (PCV13) (target 30 per dose group). ASP3772 vaccine was safe, well tolerated in adults aged 18-64 years, and exhibited robust immunogenicity that extended beyond serotypes shared with PCV13."

Clinical • Infectious Disease

Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects (clinicaltrials.gov) - P1; N=126; Recruiting; Sponsor: Astellas Pharma Inc; Trial completion date: Sep 2020 ➔ Mar 2021; Trial primary completion date: Sep 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator (clinicaltrials.gov) - P1; N=75; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.

New P1 trial • Infectious Disease

Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects (clinicaltrials.gov) - P1; N=126; Recruiting; Sponsor: Astellas Pharma Inc; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open

A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine (clinicaltrials.gov) - P1/2; N=618; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Apr 2020 ➔ Nov 2020; Trial primary completion date: Apr 2020 ➔ Nov 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects (clinicaltrials.gov) - P1; N=126; Active, not recruiting; Sponsor: Astellas Pharma Inc; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects (clinicaltrials.gov) - P1; N=126; Recruiting; Sponsor: Astellas Pharma Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects (clinicaltrials.gov) - P1; N=126; Not yet recruiting; Sponsor: Astellas Pharma Inc

Clinical • New P1 trial