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Lot-to-lot immunoge...
Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults
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- Ferguson, Murdo (författare)
- Colchester Research Group, Canada,Colchester Res Grp, Truro, NS B2N 1L2, Canada.
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- Murray, Alexander (författare)
- PharmQuest, 806 Green Valley Rd Ste 305, Greensboro, NC 27408 USA.
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- Pliamm, Lew (författare)
- Canadian Phase Onward Inc, Polyclin Family & Specialty Med Facil, Polyclin Family Hlth Grp, 2 Champagne Dr, Toronto, ON M3J 0K2, Canada.
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- Rombo, Lars (författare)
- Uppsala universitet,Uppsala University,Centrum för klinisk forskning i Sörmland (CKFD),Institutionen för medicinsk biokemi och mikrobiologi,Clinical Research Centre Sörmland
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- Sanmartin Berglund, Johan, Professor (författare)
- Blekinge Institute of Technology,Lund University,Lunds universitet,Blekinge Tekniska Högskola,Institutionen för hälsa,Geriatrik,Forskargrupper vid Lunds universitet,Geriatric Medicine,Lund University Research Groups,Geriatrics,Blekinge Inst Technol, Dept Hlth, Valhallavagen 1, SE-37179 Karlskrona, Sweden.;Lund Univ, Dept Clin Sci, BMC I12, SE-22184 Lund, Sweden.
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- David, Marie-Pierre (författare)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium.,GlaxoSmithKline Pharmaceuticals SA
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- De Schrevel, Nathalie (författare)
- GSK, Rue Inst 89, B-1330 Rixensart, Belgium.,GlaxoSmithKline Pharmaceuticals SA
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- Maschino, Franck (författare)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium.,GlaxoSmithKline Pharmaceuticals SA
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- Kotb, Shady (författare)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium.,GlaxoSmithKline Pharmaceuticals SA
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- Olivier, Aurélie (författare)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium.,GlaxoSmithKline Pharmaceuticals SA
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- Hulstrøm, Veronica (författare)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium.,GlaxoSmithKline Pharmaceuticals SA
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Colchester Research Group, Canada Colchester Res Grp, Truro, NS B2N 1L2, Canada (creator_code:org_t)
- Elsevier, 2024
- 2024
- Engelska.
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Ingår i: Vaccine: X. - : Elsevier. - 2590-1362. ; 18
- Relaterad länk:
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https://doi.org/10.1...
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https://bth.diva-por... (primary) (Raw object)
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http://dx.doi.org/10... (free)
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- Background: Previous phase 3 studies showed that the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) is well tolerated and efficacious in preventing RSV-associated lower respiratory tract disease in adults ≥ 60 years of age. This study evaluated lot-to-lot immunogenicity consistency, reactogenicity, and safety of three RSVPreF3 OA lots. Methods: This phase 3, multicenter, double-blind study randomized (1:1:1) participants ≥ 60 years of age to receive one of three RSVPreF3 OA lots. Serum RSVPreF3-binding immunoglobulin G (IgG) concentration was assessed at baseline and 30 days post-vaccination. Lot-to-lot consistency was demonstrated if the two-sided 95 % confidence intervals (CIs) of the RSVPreF3-binding IgG geometric mean concentration (GMC) ratios between each lot pair at 30 days post-vaccination were within 0.67 and 1.50. Solicited adverse events (AEs) within four days, unsolicited AEs within 30 days, and serious AEs (SAEs) and potential immune-mediated diseases within six months post-vaccination were recorded. Results: A total of 757 participants received RSVPreF3 OA, of whom 708 were included in the per-protocol set (234, 237, and 237 participants for each lot). Lot-to-lot consistency was demonstrated: 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 (lot 1/2; 1/3; 2/3). For the three lots, the RSVPreF3-binding IgG concentration increased 11.84-, 11.29-, and 12.46-fold post-vaccination compared to baseline. The reporting rates of solicited and unsolicited AEs, SAEs, and potential immune-mediated diseases were balanced between lots. Twenty-one participants reported SAEs; one of these–a case of atrial fibrillation–was considered by the investigator as vaccine-related. SAEs with a fatal outcome were reported for four participants, none of which were considered by the investigator as vaccine-related. Conclusion: This study demonstrated lot-to-lot immunogenicity consistency of three RSVPreF3 OA vaccine lots and indicated that the vaccine had an acceptable safety profile. ClinicalTrials.gov: NCT05059301. © 2024 GSK
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Geriatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Geriatrics (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Annan medicin och hälsovetenskap -- Gerontologi, medicinsk/hälsovetenskaplig inriktning (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Other Medical and Health Sciences -- Gerontology, specialising in Medical and Health Sciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Mikrobiologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Microbiology in the medical area (hsv//eng)
Nyckelord
- Immunogenicity
- Lot-to-lot consistency
- Older adults
- Prefusion F protein vaccine
- Respiratory syncytial virus
- Safety
- immunoglobulin G
- respiratory syncytial virus prefusion F protein vaccine
- respiratory syncytial virus vaccine
- unclassified drug
- adult
- aged
- arthralgia
- Article
- atrial fibrillation
- confidence interval
- controlled study
- double blind procedure
- drug safety
- erythema
- fatigue
- female
- fever
- follow up
- headache
- human
- immunoglobulin blood level
- lot to lot immunogenicity
- male
- middle aged
- multicenter study
- myalgia
- pain
- phase 3 clinical trial
- randomized controlled trial
- respiratory syncytial virus infection
- swelling
- vaccination
- vaccine immunogenicity
- very elderly
- Immunogenicity
- Lot-to-lot consistency
- Older adults
- Prefusion F protein vaccine
- Respiratory syncytial virus
- Safety
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Ferguson, Murdo
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Murray, Alexande ...
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Pliamm, Lew
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Rombo, Lars
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Sanmartin Berglu ...
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David, Marie-Pie ...
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De Schrevel, Nat ...
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Maschino, Franck
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Kotb, Shady
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Olivier, Aurélie
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Hulstrøm, Veroni ...
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och Geriatrik
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kardiologi
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Annan medicin oc ...
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och Gerontologi medi ...
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- Artiklar i publikationen
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Vaccine: X
- Av lärosätet
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Blekinge Tekniska Högskola
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Lunds universitet
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Uppsala universitet