ArticleSpringerPlus2014
Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study.
Article in SpringerPlus, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01494740 (Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants), which is not on this map. Not yet cited in PubMed.
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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.
Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants
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0 citing papers in PubMed, 0 citations in OpenAlex.
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
abstractThe aim of this study is to further investigate the immune response of the inactivated split-virion vaccine for infants. We tested the immunogenicity and safety of the inactivated split-virion vaccine in infants, aged 6-35 months, for a randomized, observer-masked, age-stratified clinical study. We randomly divided subjects into three groups: 7.5 μg, 15 μg of hemagglutinin antigen dosage groups and seasonal influenza vaccine for children dosage group in a 2 dose regimen. A serologic analysis was performed at baseline and on day 21 and 42. 312 infants received a single dose injection of vaccine and 265 (84.94%) infants received two doses injection of vaccine. Adverse reactions were mostly mild or moderate. Among the subjects who received 7.5 μg and 15 μg of vaccine for a single dose injection, the rate of hemagglutinin inhibition titer of 1:40 or greater were 52.48% (95% confidence interval (CI) 42.83 ~ 61.95) and 61.11% (95% CI 50.78 ~ 70.53), respectively. Among the subjects receiving 7.5 μg and 15 μg of vaccine for two doses injection, the rate of hemagglutinin inhibition (HI) titer of 1:40 or greater were 90.10% (95% CI 82.73 ~ 94.53) and 94.44% (95% CI 87.64 ~ 97.60), respectively. These data suggests that 15 μg or 7.5 μg dose of hemagglutinin antigen of the inactivated split-virion vaccine was safe and two doses of injection could induce a sufficient protective immune response in infants.
trial registrationCLINICAL TRIALS REGISTRATION: NCT01494740.
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