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
BACKGROUND: Respiratory syncytial virus (RSV) illness and pneumococcal disease present high disease burden and health risks to older adults. Vaccination against these two illnesses is a key strategy to reduce this burden, and co-administration of the two vaccines could enhance vaccine uptake. This study evaluated the immunogenicity, safety and reactogenicity of co-administration of adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) with 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged ≥60 years. METHODS: This phase III, open-label, randomized, non-inferiority trial was conducted across 38 centers in Belgium, Poland, Spain and the United States. Participants (N=1112) were randomized 1:1 to receive adjuvanted RSVPreF3 vaccine and PCV20 vaccine either concomitantly (Co-Ad group) or one month apart (Control group). The primary objectives were to assess immunogenicity as measured by RSV-A and RSV-B neutralizing titers, and opsonophagocytic titers for the PCV20 serotypes. Safety and reactogenicity were assessed as secondary objectives. RESULTS: All primary immunogenicity objectives were met. The upper limit of the 95% confidence interval of the geometric mean titer ratios for RSV-A, RSV-B and all twenty PCV20 serotypes were within the pre-defined non-inferiority margins. Safety profiles were similar across both groups, with most adverse events being mild to moderate in severity and of short duration. Serious adverse events and potential immune-mediated diseases were rare and unrelated to vaccination. CONCLUSIONS: Co-administration of adjuvanted RSVPreF3 vaccine and PCV20 vaccine in older adults is immunologically non-inferior to their sequential administration, with an acceptable safety profile. These findings support co-administration as a strategy to enhance vaccine uptake.
Authors
- Agnieszka Jurek-Urbanowska
- Carlos Brotons Cuixart
- Jacqueline Elaine Akite
- Isabel Leroux‐Roels (ORCID: https://orcid.org/0000-0002-5084-4696)
- Przemysław Borowy (ORCID: https://orcid.org/0000-0002-6578-0699)
- Dominique Wauters
- Muriel Lins (ORCID: https://orcid.org/0009-0006-0989-4268)
- Rachel M. Presti (ORCID: https://orcid.org/0000-0002-5469-0727)
- Patrick H. P. Soentjens (ORCID: https://orcid.org/0000-0002-2495-1199)
- Archana Jastorff
- Ronald Surowitz
- Patrick Dennis
- Manuchehr Darani
- Joseph Soufer
- Marie Van der Wielen (ORCID: https://orcid.org/0009-0006-3808-8767)
- Madhavi Ampajwala
- Abram H. Burgher
- Antoinette Pragalos
- Fernando Cereto Castro
- Miguel Trevino
- Amulya Jayadev
- Bruce Rankin
- Vicky Cárdenas
- Katarzyna Wawrzyniec-Lis
- Ewa Krecipro Nizinska
- the RSV-019 study group
- Tatyana Miroshnikova
- Lina Perez Breva
- Luc Capiau
- Adeyemi Gbohunmi
- Paulia Kwo Ton Ge Jua
- Klaas Vercruysse
- Magda Dabrowska
- William Nixon
- Kathleen Jones
- Sander Gothard
- Jean Benoit Martinot
- Shital Upadhyay
- Rica Santiago
- Jay Sandberg
- Salma Saiger
Institutions
- Ghent University Hospital (BE)
- American University of Integrative Sciences (SX)
- GlaxoSmithKline (Belgium) (BE)
- GlaxoSmithKline (India) (IN)
- GlaxoSmithKline (United States) (US)
- Jupiter Medical Center (US)
- Christ Hospital (US)
- Christ Hospital (US)
- Bangalore University (IN)
Publication Details
- Journal
- Clinical Infectious Diseases
- Published
- 2026-04-10
- DOI
- https://doi.org/10.1093/cid/ciag250
- Primary Topic
- Respiratory viral infections research
- Type
- article
- Field-Weighted Citation Impact
- 0.00