Trial reportThe Journal of infectious diseases2013
Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children.
Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01198756 (Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine), which is not on this map. Cited by 27 papers.
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.
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children
Who cites it
27 citing papers in PubMed, 66 citations in OpenAlex.
- Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine in children and adolescents 6 months through 17 years of age in India.Human vaccines & immunotherapeutics · 2022Trial
- Immunogenicity and safety of the first indigenously developed Indian tetravalent influenza vaccine (split virion) in healthy children (6 months to 17 years of age): a randomized, multicenter, phase III clinical trial.Human vaccines & immunotherapeutics · 2021Trial
- Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6-35 months in China.Human vaccines & immunotherapeutics · 2020Trial
- Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naïve Children.The Pediatric infectious disease journal · 2019Trial
- Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults.BMC infectious diseases · 2018Trial
- 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
- A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine.BMC infectious diseases · 2014Trial
- Boosting the influenza vaccine schedule in children with cancer: a prospective open-label study.NPJ vaccines · 2025Article
- Phase I Clinical Study of the Subunit Betulin-Adjuvanted Tetravalent Candidate Influenza Vaccine TetraFluBet.Vaccines · 2024Article
- Analysis of the adverse events following immunization with inactivated quadrivalent influenza vaccine from 2018 to 2020 in Zhejiang province, with a comparison to trivalent influenza vaccine.Human vaccines & immunotherapeutics · 2021Article
- Article
- Forty five percent of the Israeli population were infected with the influenza B Victoria virus during the winter season 2015-16.Oncotarget · 2018Article
- A review of the value of quadrivalent influenza vaccines and their potential contribution to influenza control.Human vaccines & immunotherapeutics · 2017Review
- Is the impact of childhood influenza vaccination less than expected: a transmission modelling study.BMC infectious diseases · 2017Article
- Cost-effectiveness of seasonal quadrivalent versus trivalent influenza vaccination in the United States: A dynamic transmission modeling approach.Human vaccines & immunotherapeutics · 2017Article
- Quadrivalent influenza vaccine: a new opportunity to reduce the influenza burden.Journal of preventive medicine and hygiene · 2016Review
- Available influenza vaccines: immunization strategies, history and new tools for fighting the disease.Journal of preventive medicine and hygiene · 2016Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
20 authors at 12 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently.
methodsIn a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3-17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6-35 months of age.
resultsA total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination-inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam).
conclusionQIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs. CLINICAL TRIALS REGISTRATION: NCT01198756.
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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.