Trial reportBMC infectious diseases2009
Challenge of conducting a placebo-controlled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: a concrete example.
Trial report in BMC infectious diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00197223 (A Randomized, Double-blind, Placebo-controlled, Post-marketing Phase III Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine), which is not on this map. Cited by 39 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Post-marketing Phase III Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults.
Who cites it
39 citing papers in PubMed, 4 syntheses or guidelines pooled it, 82 citations in OpenAlex.
- Vaccines for preventing influenza in healthy adults.The Cochrane database of systematic reviews · 2018Pooled it
- Comparing influenza vaccine efficacy against mismatched and matched strains: a systematic review and meta-analysis.BMC medicine · 2013Pooled it
- Effectiveness and harms of seasonal and pandemic influenza vaccines in children, adults and elderly: a critical review and re-analysis of 15 meta-analyses.Human vaccines & immunotherapeutics · 2012Pooled it
- Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis.PloS one · 2011Pooled it
- Long-term efficacy and safety of the single-dose tetravalent Butantan dengue vaccine.Nature medicine · 2026Trial
- Inosine pranobex is safe and effective for the treatment of subjects with confirmed acute respiratory viral infections: analysis and subgroup analysis from a Phase 4, randomised, placebo-controlled, double-blind study.BMC infectious diseases · 2016Trial
- Immunogenicity and safety of a cell culture-based quadrivalent influenza vaccine in adults: A Phase III, double-blind, multicenter, randomized, non-inferiority study.Human vaccines & immunotherapeutics · 2016Trial
- Genetic and antigenic typing of seasonal influenza virus breakthrough cases from a 2008-2009 vaccine efficacy trial.Clinical and vaccine immunology : CVI · 2014Trial
- Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged ≥18 years.BMC infectious diseases · 2013Trial
- Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults.BMC infectious diseases · 2013Trial
- A cell culture-derived influenza vaccine provides consistent protection against infection and reduces the duration and severity of disease in infected individuals.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012Trial
- Immunologic non-inferiority of a newly licensed inactivated trivalent influenza vaccine versus an established vaccine: a randomized study in US adults.Human vaccines · 2011Trial
- Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons.BMC infectious diseases · 2010Trial
- Review
- Review
- FluB-RAM and FluB-RANS: Genome Rearrangement as Safe and Efficacious Live Attenuated Influenza B Virus Vaccines.Vaccines · 2021Article
- Cost-Effectiveness Analysis of Switching from Trivalent to Quadrivalent Seasonal Influenza Vaccine in Argentina.Vaccines · 2021Article
- Article
- Reverse genetics for influenza B viruses and recent advances in vaccine development.Current opinion in virology · 2020Review
- Epidemiology and Genetic Variability of Circulating Influenza B Viruses in Uruguay, 2012-2019.Microorganisms · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOur aim was to determine the efficacy of a trivalent inactivated split virus influenza vaccine (TIV) against culture-confirmed influenza A and/or B in adults 18 to 64 years of age during the 2005/2006 season in the Czech Republic.
methods6203 subjects were randomized to receive TIV (N = 4137) or placebo (N = 2066). The sample size was based on an assumed attack rate of 4% which provided 90% power to reject the hypothesis that vaccine efficacy (VE) was > or = 45%. Cases of influenza like illness (defined as fever (oral temperature > or =37.8 degrees C) plus cough and/or sore throat) were identified both by active (biweekly phone contact) and passive (self reporting) surveillance and nasal and throat swabs were collected from subjects for viral culture.
resultsTIV was well tolerated and induced a good immune response. The 2005/2006 influenza season was exceptionally mild in the study area, as it was throughout Europe, and only 46 culture-confirmed cases were found in the study cohort (10 influenza A and 36 influenza B). Furthermore among the B isolates, 35 were identified as B/Hong Kong 330/2001-like (B/Victoria/2/87 lineage) which is antigenically unrelated to the vaccine B strain (B/Yamagata/16/88 lineage). The attack rate in the vaccine group (0.7%) was not statistically significantly different from the attack rate in the placebo group (0.9%).
conclusionDue to the atypical nature of the influenza season during this study we were unable to assess TIV efficacy. This experience illustrates the challenge of conducting a prospective influenza vaccine efficacy trial during a single season when influenza attack rates and drift in circulating strains or B virus lineage match can be difficult to estimate in advance.
trial registrationClinical trial registery: NCT00197223.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.