Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine
Abstract
1. Introduction
2. Methods
2.1. Design
2.2. Safety Parameters
2.3. Statistical Analysis
3. Results
3.1. Populations
3.2. Local Reactions and Systemic Events Among ≥18-Year-Olds
3.3. Adverse Drug Reactions Among ≥18-Year-Olds
3.4. Adverse Events Among 18- Through 59-Year-Olds
3.5. Related Adverse Events Among ≥18-Year-Olds
3.6. Post-Marketing Adverse Events
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Study Name/Number (NCT Number) | Design | Location | Population | Number of Participants ≥18 Years of Age | |
---|---|---|---|---|---|
Total Randomized | Included in Safety Analysis | ||||
C3671001 (NCT03529773) [20,21] | Phase 1/2 randomized, placebo-controlled, observer-blind, dose-finding first-in-human study | United States | Healthy male and non-pregnant female participants 50–85 years of age | 617 | 291 * |
C3671004 (NCT04071158) [22] | Phase 2b randomized, placebo-controlled, multi-center, observer-blind, noninferiority study | United States | Healthy non-pregnant female participants 18–49 years of age receiving concomitant Tdap | 427 | 421 |
WI257521 (NCT04785612) [23] | Phase 2a, randomized, placebo-controlled, single-center, double-blind, exploratory human challenge study | United Kingdom | Healthy male and non-pregnant female participants 19–50 years of age | 70 | 70 |
RENOIR (NCT05035212) [15] | Phase 3, randomized, placebo-controlled, multi-center, double-blind study | Argentina, Canada, Finland, Japan, Netherlands, South Africa, United States | Healthy † male and non-pregnant participants 59–97 years of age | 36,862 | 36,862 |
C3671014 (NCT05096208) [24] | Phase 3, randomized, placebo-controlled, multi-center, double-blind, lot consistency study | United States | Healthy male and non-pregnant female participants 18–49 years of age | 993 | 992 |
MONET Substudy A (NCT05842967) [25] | Phase 3, randomized, placebo-controlled, multi-center, double-blind study | United States | Healthy male and non-pregnant female participants 18–59 years of age and at high risk of severe RSV disease | 681 | 678 |
C3671003 (NCT04032093) [26] | Phase 2b, observer-blinded, randomized, placebo-controlled, dose-finding and proof-of-concept study | Argentina, Chile, South Africa, United States | Healthy pregnant female participants 18–49 years of age | 232 | 232 |
MATISSE (NCT04424316) [14,27] | Phase 3, multi-center, double-blinded, placebo-controlled trial | Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Gambia, Japan, Mexico, Netherlands, New Zealand, Philippines, Republic of Korea, South Africa, Spain, Taiwan, United States | Healthy pregnant female participants 14–47 years of age | 7420 | 7367 |
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Ilangovan, K.; Radley, D.; Patton, M.; Shittu, E.; Lino, M.M.; Goulas, C.; Swanson, K.A.; Anderson, A.S.; Gurtman, A.; Munjal, I. Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine. Vaccines 2025, 13, 827. https://doi.org/10.3390/vaccines13080827
Ilangovan K, Radley D, Patton M, Shittu E, Lino MM, Goulas C, Swanson KA, Anderson AS, Gurtman A, Munjal I. Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine. Vaccines. 2025; 13(8):827. https://doi.org/10.3390/vaccines13080827
Chicago/Turabian StyleIlangovan, Kumar, David Radley, Michael Patton, Emma Shittu, Maria Maddalena Lino, Christos Goulas, Kena A. Swanson, Annaliesa S. Anderson, Alejandra Gurtman, and Iona Munjal. 2025. "Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine" Vaccines 13, no. 8: 827. https://doi.org/10.3390/vaccines13080827
APA StyleIlangovan, K., Radley, D., Patton, M., Shittu, E., Lino, M. M., Goulas, C., Swanson, K. A., Anderson, A. S., Gurtman, A., & Munjal, I. (2025). Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine. Vaccines, 13(8), 827. https://doi.org/10.3390/vaccines13080827