ArticleAmerican journal of epidemiology2018
Competing Effects of Indirect Protection and Clustering on the Power of Cluster-Randomized Controlled Vaccine Trials.
Article in American journal of epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed.
- Trial
- Design of field trials for the evaluation of transmissible vaccines in animal populations.PLoS computational biology · 2025Article
- A post-marketing study to evaluate the safety and immunogenicity of a quadrivalent influenza split-virion vaccine in elderly people aged 60 years and older.Tropical diseases, travel medicine and vaccines · 2024Article
- Public Health Impacts of Vaccines for COVID-19 and Beyond: Opportunities to Overcome Technical and Regulatory Barriers for Randomized Trials.American journal of public health · 2023Article
- Randomization, design and analysis for interdependency in aging research: no person or mouse is an island.Nature aging · 2022Article
- The ring vaccination trial design for the estimation of vaccine efficacy and effectiveness during infectious disease outbreaks.Clinical trials (London, England) · 2022Article
- The required size of cluster randomized trials of nonpharmaceutical interventions in epidemic settings.Statistics in medicine · 2022Article
- Quantifying Efficiency Gains of Innovative Designs of Two-Arm Vaccine Trials for COVID-19 Using an Epidemic Simulation Model.Statistics in biopharmaceutical research · 2022Article
- Using simulated infectious disease outbreaks to inform site selection and sample size for individually randomized vaccine trials during an ongoing epidemic.Clinical trials (London, England) · 2021Article
- Looking beyond COVID-19 vaccine phase 3 trials.Nature medicine · 2021Review
- Potential Biases Arising From Epidemic Dynamics in Observational Seroprotection Studies.American journal of epidemiology · 2021Article
- Statistical Properties of Stepped Wedge Cluster-Randomized Trials in Infectious Disease Outbreaks.American journal of epidemiology · 2020Article
- Potential biases arising from epidemic dynamics in observational seroprotection studies.medRxiv : the preprint server for health sciences · 2020Article
- Novel methods for the analysis of stepped wedge cluster randomized trials.Statistics in medicine · 2020Article
- Choices in vaccine trial design in epidemics of emerging infections.PLoS medicine · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
Power considerations for trials evaluating vaccines against infectious diseases are complicated by indirect protective effects of vaccination. While cluster-randomized controlled trials (cRCTs) are less statistically efficient than individually randomized controlled trials (iRCTs), a cRCT's ability to measure direct and indirect vaccine effects may mitigate the loss of efficiency due to clustering. Within cRCTs, the number and size of clusters affects 3 determinants of power: the effect size being measured, disease incidence, and intracluster correlation. We simulated trials conducted in a collection of small communities to assess how indirect protection and clustering affected the power of cRCTs and iRCTs during an emerging epidemic. Across diverse parameters, we found that within the same trial population, cRCTs were never more powerful than iRCTs, although the difference can be small. We also identified 2 effects that attenuated the loss of cRCT power traditionally associated with increased cluster size. First, if enrollment of fewer, larger clusters was performed to achieve higher vaccine coverage within vaccinated communities, this increased the effect to be measured and, consequently, power. Second, the greater rate of imported transmission in larger communities may increase the attack rate and similarly mitigate loss of power relative to a trial in many, smaller communities.
Indexed as
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.