ArticleJournal of the Pediatric Infectious Diseases Society2012
Immunogenicity and Safety of 2 Dose Levels of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine in Children Aged 6-35 Months: A Randomized, Controlled Trial.
Article in Journal of the Pediatric Infectious Diseases Society, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00778895 (Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control), which is not on this map. Cited by 22 papers.
What it found
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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.
Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Who cites it
22 citing papers in PubMed, 40 citations in OpenAlex.
- Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6-35 months of age in China: A randomized, double-blind, clinical trial.Human vaccines & immunotherapeutics · 2024Trial
- Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial.The Pediatric infectious disease journal · 2019Trial
- Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial.Journal of the Pediatric Infectious Diseases Society · 2017Trial
- Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial.Journal of the Pediatric Infectious Diseases Society · 2016Trial
- Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.Journal of the Pediatric Infectious Diseases Society · 2015Trial
- Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial.Human vaccines & immunotherapeutics · 2015Trial
- Trial
- A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age.Human vaccines & immunotherapeutics · 2013Trial
- Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children.The Journal of infectious diseases · 2013Trial
- Summary of the National Advisory Committee on Immunization (NACI) Statement-Recommendations on Fractional Influenza Vaccine Dosing in the Event of a Shortage: Pandemic preparedness.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2023Article
- Summary of the National Advisory Committee on Immunization (NACI) Seasonal Influenza Vaccine Statement for 2022-2023.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2022Article
- Safety and effectiveness of dose-sparing strategies for intramuscular seasonal influenza vaccine: a rapid scoping review.BMJ open · 2021Article
- Summary of the National Advisory Committee on Immunization (NACI) Seasonal Influenza Vaccine Statement for 2021-2022.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2021Article
- Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review.Frontiers in immunology · 2021Review
- Summary of the NACI Seasonal Influenza Vaccine Statement for 2020-2021.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2020Article
- Summary of the NACI Seasonal Influenza Vaccine Statement for 2019-2020.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2019Article
- Summary of the NACI Seasonal Influenza Vaccine Statement for 2018-2019.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2018Article
- Influenza vaccines: Evaluation of the safety profile.Human vaccines & immunotherapeutics · 2018Review
- Vaccine approaches conferring cross-protection against influenza viruses.Expert review of vaccines · 2017Review
- Summary of the NACI Statement on Seasonal Influenza Vaccine for 2017-2018.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2017Article
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 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImproved influenza vaccine strategies for infants and preschool children are a high priority.
methodsThe immunological response and safety of a thimerosal-free trivalent inactivated influenza vaccine at 2 different doses (0.50 mL vs 0.25 mL) was evaluated in children aged 6-35 months. The study was randomized, observer blind, multicenter, and stratified by age (6-23 months and 24-35 months), and it accounted for prior influenza immunization status.
resultsThree hundred seventy-four children were in the total vaccinated cohort (study vaccine 0.25-mL dose, n = 164; 0.50-mL dose, n = 167; comparator 0.25 mL, n = 43). Regulatory criteria for immunogenicity of influenza vaccines in adults were met for all virus strains and doses for both age strata. A modest but not statistically significant improvement in immune responses was observed with the higher dose and reactogenicity, and safety of the 2 doses was not significantly different.
conclusionsThe 0.5-mL dose of the study vaccine, when administered to children aged 6-35 months, resulted in a modest but not statistically significant improvement in immunogenicity with clinically similar safety and reactogenicity compared with the 0.25-mL dose. Further studies comparing full- and half-dose influenza vaccine in young children are needed. CLINICAL TRIALS REGISTRATION: NCT00778895.
Identifiers
What OpenQuestion holds
Registered trials
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.