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Søgning på udtrykket 'phase 3' giver 26 resultater
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Clinical Infectious Diseases
26.12.2024
Abstract . Background . A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the five meningococcal serogroups that cause most invasive disease cases.Methods . In this phase 3 study (NCT04707391), healthy participants aged 15–25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive two MenABCWY doses six months apart or one MenACWY-CRM dose. Primary objectives were to demonstrate the non-inferiority of M…
Antimicrobial Agents And Chemotherapy
20.12.2024
Antimicrobial Agents and Chemotherapy, Ahead of Print.
Lancet Infectious Diseases
6.12.2024
This study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0–6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB. This investigational vaccine could provide broad meningococcal serogroup coverage in a simplified immunisation schedule, thus aiding…
Clinical Infectious Diseases
5.12.2024
… tract infection (LRTI) in infants and medically vulnerable children (aged ≤24 months). This post-hoc exploratory analysis examined the incidence of LRTI from RSV and other respiratory pathogens during a 2:1 randomized, double-blind, placebo-controlled, phase 3 study of nirsevimab, in healthy-term and late-preterm (i.e. gestational age ≥35 weeks) infants entering their first RSV season (MELODY).Methods . 3012 participants were randomized to nirsevimab (n = 2009) or placebo (n = 1003). Nasopharyngeal swa…
Lancet
29.11.2024
These data demonstrate that beti-cel can allow patients with genotypes that cause severe β-thalassaemia (β0/β0, β0/β+IVS-I-110, or β+IVS-I-110/β+IVS-I-110) to reach transfusion independence. Beti-cel offers the potential to attain near-normal haemoglobin levels for those with severe forms of TDT, and a potentially curative option without the risks and limitations of allogeneic HSPC transplantation. Patients are being followed up for a total of 15 years to assess the durability of transfusion independ…
American Journal of Respiratory and Critical Care Medicine
28.11.2024
American Journal of Respiratory and Critical Care Medicine, Volume 210, Issue 11, Page 1358-1369, December 1, 2024.
Lancet Infectious Diseases
26.11.2024
Coadministered mRNA-1345 plus SIIV4 or mRNA-1273.214 vaccines had acceptable safety profiles and elicited mostly non-inferior immune responses compared to individual vaccines in adults aged 50 years or older; only the seroresponse rate difference in nAbs against RSV-A in part A did not meet the non-inferiority criterion. Overall, these data support coadministration of mRNA-1345 with these vaccines in this population; longer-term evaluation continues in this study.
Past, Present and Future of Phase 3 Vaccine Trial Design: Rethinking Statistics for the 21st Century
Clinical & Experimental Immunology
23.11.2024
Abstract . Vaccines are crucial for protecting health globally; however, their widespread use relies on rigorous clinical development programmes. This includes Phase 3 randomised controlled trials (RCTs) to confirm their safety, immunogenicity, and efficacy. Traditionally, such trials used fixed designs with predetermined assumptions, lacking the flexibility to change during the trial or stop early due to overwhelming evidence of either efficacy or futility. Modern vaccine trials benefit from innovative app…
Clinical Microbiology and Infection
3.11.2024
To demonstrate the noninferiority of intravenous (IV) sulopenem to IV ertapenem, each followed by an oral regimen, in adults with complicated intraabdominal infections (cIAI).
Lancet Infectious Diseases
24.10.2024
Boosting mRNA-immunised adults with ARCT-2301 induced superior immunogenicity compared with Comirnaty BA.4-5 against both Wuhan-Hu-1 and omicron BA.4/5 variant COVID-19, and elicited a higher response against omicron XBB.1.5. Both vaccines had similar tolerability profiles. Self-amplifying mRNA vaccines could provide a substantial contribution to pandemic preparedness and response, inducing robust immune responses with a lower dose of mRNA to allow wider and more equitable distribution.
Lancet Infectious Diseases
24.10.2024
Interference between passive immunity and vaccine response is clinically significant and might affect the implementation of next-generation CSP-based vaccines for young infants and mothers as well as passive immunisation with human monoclonal antibodies.
Lancet Infectious Diseases
8.10.2024
These phase 3 efficacy and safety data provide support for aztreonam–avibactam as a potential therapeutic option for complicated intra-abdominal infection or HAP–VAP caused by Gram-negative bacteria.
Lancet Respiratory Medicine
2.10.2024
The data from PROMIS-I suggest a clinically important benefit of colistimethate sodium delivered via the I-neb adaptive aerosol delivery system in patients with bronchiectasis and P aeruginosa infection. These results were not replicated in PROMIS-II, which was affected by the COVID-19 pandemic and prematurely terminated.
Journal of Medical Virology
25.09.2024
Journal of Medical Virology, Volume 96, Issue 9, September 2024.
Journal of Infectious Diseases
23.09.2024
Abstract . Background . Among 547 patients receiving maribavir or valganciclovir for first-episode cytomegalovirus infection after hematopoietic cell transplant, the treatment response rate was 69.6% and 77.4% respectively. Development of maribavir and ganciclovir resistance was compared after receiving either drug.Methods . Viral mutations conferring drug resistance were analyzed in plasma DNA extracts at baseline and post-treatment.Results . Prior antiviral drug exposure was limited, with only 2 instances…
Journal of Infectious Diseases
6.09.2024
…us disease 2019 (COVID-19) vaccines reduce severe disease and mortality and may lessen transmission, measured by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL). Evaluating vaccine associations in VL at COVID-19 diagnosis in 4 phase 3 randomized, placebo-controlled vaccine trials, July 2020 to July 2021, VL reductions were 2.78 log10 copies/mL (95% confidence interval [CI], 1.38–4.18; n = 60 placebo, 11 vaccine) and 2.12 log10 copies/mL (95% CI, 1.44–2.80; n = 594 placebo, 3…
Lancet Infectious Diseases
5.09.2024
VLA1553 was generally safe and induced seroprotective titres in almost all vaccinated adolescents with favourable safety data in adolescents who were seropositive at baseline. The data support the use of VLA1553 for the prevention of disease caused by the chikungunya virus among adolescents and in endemic areas.
Lancet Infectious Diseases
13.08.2024
After a single VLA1553 vaccination, chikungunya virus-neutralising antibodies above the threshold considered to be protective persisted up to 2 years and there were no long-term serious adverse events related to vaccination. VLA1553 is an efficient and safe intervention that offers high seroprotection against chikungunya virus infection, a virus likely to spread globally with an urgent demand for long-lasting prophylaxis.
Lancet Infectious Diseases
6.08.2024
A single dose of Butantan-DV was generally well tolerated and efficacious against symptomatic VCD (caused by DENV-1 and DENV-2) for a mean of 3·7 years. These findings support the continued development of Butantan-DV to prevent dengue disease in children, adolescents, and adults regardless of dengue serostatus.
Clinical Infectious Diseases
5.08.2024
Abstract . Background . We evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds.Methods . This phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequent…
Aktuelle smitsomme sygdomme [6]
Aktuelle smitsomme sygdomme [6]
Medscape Infectious Diseases
30.10.2024
Japan's Shionogi & Co said on Tuesday a global, late-stage study showed its pill-based treatment for COVID-19 was effective in reducing transmission of the. . Reuters Health Information
Medscape Infectious Diseases
12.02.2024
The vaccine protected children under the age of 1.5 years against infection with an efficacy of 68%-75%. . Medscape Medical News
Medscape Infectious Diseases
8.10.2024
Two different doses of crisugabalin resulted in significantly greater pain reductions in adults with postherpetic neuralgia than placebo in a phase 3 trial. . Medscape Medical News
Medscape Infectious Diseases
5.07.2024
Patients at a high risk for HIV infection who received preexposure prophylactic injections with lenacapavir had 100% efficacy in a phase 3 clinical trial. . Medscape Medical News
Medscape Infectious Diseases
23.03.2024
Findings from two phase 3 trials demonstrate that the aztreonam-avibactam combination safely treats gram-negative bacterial infections. . Medscape Medical News
Medscape Infectious Diseases
14.03.2024
With a maternal vaccine already on the market to protect newborns from RSV, the outlook for another looked promising, but latest phase 3 trial of a new candidate is now halted over safety concerns. . Medscape Medical News