Trial reportInfluenza and other respiratory viruses2009
Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in infants and children.
Trial report in Influenza and other respiratory viruses, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Wheeze as an adverse event in pediatric vaccine and drug randomized controlled trials: A systematic review.Vaccine · 2015Pooled it
- Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial.Human vaccines & immunotherapeutics · 2016Trial
- Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents.Influenza and other respiratory viruses · 2013Trial
- Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.BMJ open · 2020Article
- Microneedle-Mediated Vaccine Delivery to the Oral Mucosa.Advanced healthcare materials · 2019Review
- Prior vaccinations improve immunogenicity of inactivated influenza vaccine in young children aged 6 months to 3 years: A cohort study.Medicine · 2018Observational
- The manufacturing process should remain the focus for severe febrile reactions in children administered an Australian inactivated influenza vaccine during 2010.Influenza and other respiratory viruses · 2016Review
- Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future.Vaccines · 2014Review
- Immunogenicity of the trivalent inactivated influenza vaccine in young children less than 4 years of age, with a focus on age and baseline antibodies.Clinical and vaccine immunology : CVI · 2014Article
- Increased reactions to pediatric influenza vaccination following concomitant pneumococcal vaccination.Influenza and other respiratory viruses · 2013Article
- A review of the evidence to support influenza vaccine introduction in countries and areas of WHO's Western Pacific Region.PloS one · 2013Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveFew prospective studies of inactivated split virion influenza vaccine have been conducted in infants and children. Our objective was to evaluate the safety, reactogenicity and immunogenicity of a thimerosal-free inactivated influenza vaccine (Fluvax; CSL Limited, Parkville, Australia) in children aged 6 months to <9 years.
methodsA prospective, open-label, phase III clinical trial was conducted in 298 healthy children previously unvaccinated with influenza, commencing in the Southern Hemisphere 2005 autumn. Participants were divided into two groups (Group A: > or =6 months to <3 years; Group B: > or =3 years to <9 years), and received two doses of the 2005 vaccine, and one dose of the 2006 vaccine one year later (Group A: 0.25 ml per dose; Group B: 0.5 ml per dose). Vaccine safety and reactogenicity was evaluated for 30 days after each dose. Immunogenicity was assessed using hemagglutination inhibition and single radial hemolysis assays.
resultsThere were no withdrawals due to adverse events (AEs). The majority of solicited local and systemic AEs were of mild severity. A maximum intensity of severe was reported for injection site pain and fever by only 3.0% and 3.4% of participants, respectively. The vaccine was immunogenic for all antigens, with > or =95% of both younger and older children achieving seroprotection after dose 2.
conclusionsThis thimerosal-free inactivated influenza vaccine had a favorable safety profile and was immunogenic in children aged > or =6 months and <9 years. Primary and booster vaccination produced consistently immunogenic responses including in children under 3 years of age receiving 0.25 ml doses of vaccine.
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