Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years

Summary

Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the Novavax (NVX) vaccine and a 20-valent pneumococcal conjugate vaccine (PCV20) results in lower immunogenicity than the administration of either alone. The investigators will thus conduct a 4-four arm study with the following treatments: NVX plus placebo (NVX arm), PCV20 plus placebo group (PCV20 arm), NVX plus PCV20 (Combination arm), and placebo plus placebo group (Placebo arm). Vaccines and/or placebo will be administered as single doses, given as intramuscular injections on Day 1 (one in each shoulder). Subjects will be randomly assigned to one of the four arms. The outcome will be the antibody levels after 28 days.

Timeline

Start

2023-03

Primary completion

2023-07

Completion

2023-08

Publications

• Jorda A, Prager M, Pracher L, Haselwanter P, Jackwerth M, Al Jalali V, Yildiz E, Leutzendorff A, Weber M, Yourieva S, Kammerer P, Pecho T, Decaminada A, Ederer L, Wiedermann U, Weseslindtner L, Redlberger-Fritz M, Bergmann F, Zeitlinger M. Immunogenicity, safety, and reactogenicity of concomitant administration of the novavax vaccine against Omicron XBB.1.5 (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine in adults aged >/=60 years: A randomised, double-blind, placebo-controlled, non-inferiority trial. J Infect. 2025 Feb;90(2):106405. doi: 10.1016/j.jinf.2024.106405. Epub 2025 Jan 3.

Drugs

Indications