Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: A Randomized, Non-inferiority Trial.
Isabel Leroux-Roels, Muriel Lins, Ronald Surowitz et al.
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In 30 seconds
This phase III, open-label, randomized non-inferiority trial compared concomitant versus one-month-apart administration of adjuvanted RSV prefusion F protein vaccine (RSVPreF3) and 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged ≥60 years. Among 1112 participants at 38 centers, all primary immunogenicity objectives were met: the upper limits of the 95% confidence interval for geometric mean titer ratios for RSV-A, RSV-B, and all 20 PCV20 serotypes remained within prespecified non-inferiority margins. Safety profiles were similar, with most adverse events mild to moderate and short-lived.
Key findings
- All primary immunogenicity objectives were met; RSV-A, RSV-B, and all 20 PCV20 serotypes met prespecified non-inferiority margins.
- Safety profiles were similar between concomitant and sequential administration groups; most adverse events were mild to moderate and short in duration.
- Serious adverse events and potential immune-mediated diseases were rare and considered unrelated to vaccination.
Why it matters
Older adults face substantial risks from RSV and pneumococcal disease, and vaccination against both is an important prevention strategy. Evidence that these vaccines can be given together without compromising measured immune responses, and with similar safety profiles to administration one month apart, supports co-administration as a possible way to improve vaccine uptake.
What to keep in mind
The trial assessed immunogenicity, safety, and reactogenicity; the abstract does not report clinical protection against RSV or pneumococcal disease.