Trial reportThe Lancet. Global health2016
Efficacy of a Russian-backbone live attenuated influenza vaccine among young children in Bangladesh: a randomised, double-blind, placebo-controlled trial.
Trial report in The Lancet. Global health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.
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.
A Randomized, Double-Blind, Placebo-Controlled Trial on the Clinical Efficacy and Safety of a Single Dose of Trivalent Seasonal Live-Attenuated Influenza Vaccine(LAIV) Among Children Aged 24 Through 59 Months in Bangladesh
Acceptability, Cost-Effectiveness, and Capacity of a Facility-Based Seasonal Influenza Vaccination: A Study in Selected Hospitals of Bangladesh
Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparison of 2 Doses vs 1 Dose in the First Season Children Are Vaccinated Against Influenza: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Vaccines for preventing influenza in healthy children.The Cochrane database of systematic reviews · 2018Pooled it
- Nasal shedding of vaccine viruses after immunization with a Russian-backbone live attenuated influenza vaccine in India.Influenza and other respiratory viruses · 2023Trial
- Efficacy of live attenuated and inactivated influenza vaccines among children in rural India: A 2-year, randomized, triple-blind, placebo-controlled trial.PLoS medicine · 2021Trial
- Immunogenicity and Viral Shedding of Russian-Backbone, Seasonal, Trivalent, Live, Attenuated Influenza Vaccine in a Phase II, Randomized, Placebo-Controlled Trial Among Preschool-Aged Children in Urban Bangladesh.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Efficacy of inactivated trivalent influenza vaccine in rural India: a 3-year cluster-randomised controlled trial.The Lancet. Global health · 2019Trial
- Live Attenuated Influenza Vaccination Before 3 Years of Age and Subsequent Development of Asthma: A 14-year Follow-up Study.The Pediatric infectious disease journal · 2018Trial
- Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study.Drug safety · 2018Trial
- Trial
- Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Trial
- Efficacy of a Russian-backbone live attenuated influenza vaccine among children in Senegal: a randomised, double-blind, placebo-controlled trial.The Lancet. Global health · 2016Trial
- Combating respiratory diseases with mucosal vaccines.Journal of virology · 2026Review
- Article
- Addressing influenza in Bangladesh: closing evidence and policy gaps with strategic interventions.The Lancet regional health. Southeast Asia · 2025Review
- Article
- Article
- Cost-effectiveness of seasonal influenza vaccination in WHO-defined high-risk populations in Bangladesh.Journal of global health · 2024Article
- Acceptability, cost-effectiveness, and capacity of a facility-based seasonal influenza vaccination among high-risk groups: a study protocol in selected tertiary care hospitals of Bangladesh.BMC public health · 2024Article
- Clade 2.3.4.4 H5 chimeric cold-adapted attenuated influenza vaccines induced cross-reactive protection in mice and ferrets.Journal of virology · 2023Article
- The STING Ligand and Delivery System Synergistically Enhance the Immunogenicity of an Intranasal Spike SARS-CoV-2 Vaccine Candidate.Biomedicines · 2022Article
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe rates of influenza illness and associated complications are high among children in Bangladesh. We assessed the clinical efficacy and safety of a Russian-backbone live attenuated influenza vaccine (LAIV) at two field sites in Bangladesh.
methodsBetween Feb 27 and April 9, 2013, children aged 2-4 years in urban Kamalapur and rural Matlab, Bangladesh, were randomly assigned in a 2:1 ratio, according to a computer-generated schedule, to receive one intranasal dose of LAIV or placebo. After vaccination, we monitored children in weekly home visits until Dec 31, 2013, with study clinic surveillance for influenza illness. The primary outcome was symptomatic, laboratory-confirmed influenza illness due to vaccine-matched strains. Analysis was per protocol. The trial is registered with ClinicalTrials.gov, number NCT01797029.
findingsOf 1761 children enrolled, 1174 received LAIV and 587 received placebo. Laboratory-confirmed influenza illness due to vaccine-matched strains was seen in 93 (15·8%) children in the placebo group and 79 (6·7%) in the LAIV group. Vaccine efficacy of LAIV for vaccine-matched strains was 57·5% (95% CI 43·6-68·0). The vaccine was well tolerated, and adverse events were balanced between the groups. The most frequent adverse events were tachypnoea (n=86 in the LAIV group and n=54 in the placebo group), cough (n=73 and n=43), and runny nose (n=68 and n=39), most of which were mild.
interpretationThis single-dose Russian-backbone LAIV was safe and efficacious at preventing symptomatic laboratory-confirmed influenza illness due to vaccine-matched strains. LAIV programmes might reduce the burden of influenza illness in Bangladesh.
fundingThe Bill & Melinda Gates Foundation.
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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.