A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above

Summary

The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).

Timeline

Start

2021-10-01

Primary completion

2022-01-24

Completion

2022-06-30

Outcome

Met primary endpoint

paper GMC ratios were 1.06 (95 % CI: 0.94-1.21), 0.92 (0.81-1.04), and 0.87 (0.77-0.99) between the lot pairs PMID 38746060 ↗

paper were within 0.67 and 1.50. PMID 38746060 ↗

Publications

• Ferguson M, Murray A, Pliamm L, Rombo L, Sanmartin Berglund J, David MP, De Schrevel N, Maschino F, Kotb S, Olivier A, Hulstrom V. Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults. Vaccine X. 2024 Apr 27;18:100494. doi: 10.1016/j.jvacx.2024.100494. eCollection 2024 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RSVPreF3 OA	Vaccine	—	Intramuscular

Indications