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Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt

safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients. The regulatory commitment to evaluate the signal through a stepwise investigation was closed in 2014. Conclusion Lessons ... event of interest after other vaccines, and the reported time-to-onset distribution of other events following the vaccine of interest [43–45]. 1.1 Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza

Immunogenicity and Safety of an EB66 Cell-Culture-Derived Influenza A/Indonesia/5/2005(H5N1) AS03-Adjuvanted Vaccine: A Phase 1 Randomized Trial

randomized, blinded study. Healthy adults (n = 521) received 2 vaccine doses (days 0 and 21) of either investigational CC-H5N1 vaccine (1.9 µg or 3.75 µg of hemagglutinin antigen [HA] with the AS03 adjuvant ... -reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults . J Infect Dis 2010 ; 201 : 1644 - 53 . 8. Leroux-Roels I

A Randomized, Controlled, Observer-Blinded Phase 1 Study of the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine With or Without Alum Adjuvant

to preferentially maintain prefusion conformation (RSV-PreF), 128 healthy men 18–44 years old were randomized to one dose of a RSV-PreF vaccine containing 10, 30, or 60 µg of RSV-PreF antigen, with or

Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial

adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group. Conclusion. The 4–8-fold antigen-sparing adjuvanted pandemic influenza vaccine ... . Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03A-adjuvant: preliminary report of an observer-blind, randomised trial . Vaccine 2010 ; 28 : 1740

Antigenic Differences between AS03 Adjuvanted Influenza A (H1N1) Pandemic Vaccines: Implications for Pandemrix-Associated Narcolepsy Risk

risk of narcolepsy reported so far with the AS03 adjuvanted H1N1 vaccination Pandemrix has been manifold compared to the AS03 adjuvanted Arepanrix, which contained differently produced H1N1 viral antigen ... pneumococcal conjugate vaccine mainly funded by GlaxoSmithKline, and her unit received funding for a clinical trial on the safety and immunogenicity of a prototype pandemic influenza vaccine from Solvay

Phase 1 randomized controlled trial to evaluate the safety and immunogenicity of recombinant Pichia pastoris-expressed Plasmodium falciparum apical membrane antigen 1 (PfAMA1-FVO [25-545]) in healthy Malian adults in Bandiagara

Background The safety and immunogenicity of PfAMA1, adjuvanted with Alhydrogel ® was assessed in malaria–experienced Malian adults. The malaria vaccine, PfAMA1-FVO [25-545] is a recombinant protein ... AK , Guindo AB , et al. Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial . PLoS ONE . 2008 ; 3 : e1465 . 5. Sagara I , Dicko A

First-in-Human Evaluation of the Safety and Immunogenicity of an Intranasally Administered Replication-Competent Sendai Virus–Vectored HIV Type 1 Gag Vaccine: Induction of Potent T-Cell or Antibody Responses in Prime-Boost Regimens

Background. We report the first-in-human safety and immunogenicity assessment of a prototype intranasally administered, replication-competent Sendai virus (SeV)–vectored, human immunodeficiency virus ... . N Engl J Med 2009 ; 361 : 2209 - 20 . 4. Baden LR , Karita E , Mutua G , et al. Assessment of the safety and immunogenicity of 2 novel vaccine platforms for HIV-1 prevention: a randomized trial . Ann

Multi-antigen avian influenza a (H7N9) virus-like particles: particulate characterizations and immunogenicity evaluation in murine and avian models

increased splenic antigen-specific cytokines production. Conclusions The H7N9 VLPs possess desirable immunogenicity in vivo and may serve as a candidate for vaccine development against avian influenza A (H7N9 ... as an anti-viral vaccine. Similar to other influenza A viruses, H7N9 viral capsids are comprised of three primary proteins, including hemagglutinin (HA), neuraminidase (NA), and matrix protein 1 (M1

Whole-body vibration training improves balance control and sit-to-stand performance among middle-aged and older adults: a pilot randomized controlled trial

) training on knee extensor muscle power, limits of stability, and sit-to-stand performance among community-dwelling middle-aged and older adults in the United States. Methods A randomized pilot study with ... following the same training protocol. The objective of this pilot study was thus to use a randomized controlled trial to evaluate the feasibility and safety of using WBV training in the untrained elderly

The safety and immunogenicity of a MF59-adjuvanted H5N1 prepandemic influenza vaccine in healthy adults primed with homologous or heterologous H5N1 vaccines: an observational study

. Safety and immunogenicity of H5N1 vaccine among participants primed with homologous or heterologous H5N1 vaccines produced by diverse manufactures have not been reported. Methods Healthy individuals aged ... with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial . Lancet 2007 , 370 ( 9587 ): 580 - 589 . 16. Rumke HC , Bayas JM , de Juanes JR , Caso C , Richardus JH

Antibody Persistence in Adults Two Years after Vaccination with an H1N1 2009 Pandemic Influenza Virus-Like Particle Vaccine

response durations induced by VLP influenza vaccines in humans are scarce. Here, we show that subjects vaccinated with an insect cell-derived VLP vaccine, in the midst of the 2009 H1N1 influenza pandemic ... , Reich D , Aggarwal N , Connor D , Lebel MH , Gupta A , et al. Randomized, multicenter trial of a single dose of AS03-adjuvanted or unadjuvanted H1N1 2009 pandemic influenza vaccine in children 6 months to

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review

Objectives A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety. Methods Literature searches ... arthritis despite methotrexate therapy: week-112 efficacy and safety results of the open-label long-term extension of a phase III, double-blind, randomized placebo-controlled trial . Arthritis Care Res . 2015

Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections

Background Current prevention options for upper respiratory infections (URIs) are not optimal. We conducted a randomized, double-blinded, placebo-controlled pilot clinical trial to evaluate the ... effectiveness of ARMS-I, a novel intra-oral formulation in the prevention of URIs in a randomized, double-blind, placebo-controlled proof-of-concept clinical trial in healthy adults. Our data showed that the

A Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab

UC or CD were positive for anti-drug antibodies. This article provides a comprehensive review of the clinical pharmacokinetics, pharmacodynamics, exposure–efficacy relationships, and immunogenicity of ... has also been confirmed in clinical studies. In a vaccination study in healthy volunteers, vedolizumab attenuated the response to an enteral antigen challenge (oral cholera vaccine) but did not affect

Evaluation of MDCK Cell-Derived Influenza H7N9 Vaccine Candidates in Ferrets

in MDCK cells. Influenza H7N9 whole virus vaccine antigen was manufactured using a microcarrier-based culture system. Immunogenicity and protection of the vaccine candidates with three different ... with AS03 and MF59 in healthy adults Recombinant H7 DNA plasmid Vaccine, VRC-FLUDNA071-00-VP, administered alone or with monovalent influenza subunit virion H7N9vaccine (MIV) Immunogenicity and safety

Evaluation of Lactobacillus coryniformis CECT5711 strain as a coadjuvant in a vaccination process: a randomised clinical trial in healthy adults

hundred twenty-three healthy adults were randomised into three groups to follow a 6-week (wk) intervention and all received an intramuscular HAV vaccine 2 weeks after starting the intervention: 1) PRO1 ... 2016. Retrospectively registered. Lactobacillus coryniformis CECT5711; Probiotics; Immune response; Vaccine; Healthy Adults - Background There is wide evidence about how nutrition affects the immune

Long-Term Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine and Evaluation of a Booster Dose Administered to Healthy Thai Children

We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies ... , Eckels KH , Thomas SJ , Innis BL , 2014 . Safety and immunogenicity of a re-derived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial . Am J Trop Med Hyg 91

Effect of Previous-Year Vaccination on the Efficacy, Immunogenicity, and Safety of High-Dose Inactivated Influenza Vaccine in Older Adults

adults. IIV-HD improved efficacy relative to IIV-SD in a randomized controlled trial. Recent observational studies suggest that previous influenza vaccination may influence the immunogenicity and ... influenza vaccine (IIV-HD or IIV-SD) on the effect of IIV-HD (compared to IIV-SD) on safety, immunogenicity, and efficacy in older adults [ 10 ]. METHODS Overall Study Design Details of the original

Strategic Interactions in Antiviral Drug Use During an Influenza Pandemic

cooperation could be essential during a severe influenza pandemic, but we know little about how jurisdictions will interact in a scenario where highly pathogenic, drug-resistant mutant strains are able to ... oseltamivir usuage also emerged more quickly than in pre-pandemic strains7,9,10. Additionally, it appears that influenza A (H7N9) viruses are also capable of acquiring oseltamivir resistance without suffering a

Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy

. An association was identified between levels of anti-type 1 repeat antibodies and prepatent period. Significance This trial was the first to assess the efficacy of a P. vivax CSP vaccine candidate by ... safety and immunogenicity. In order to test if the vaccine can afford protection, we challenged the volunteers via the bite of infected mosquitoes, the first time such a human infection model has been used