Evidence map›Paper›PMID 39060943›Full record

ArticleTrials2024

Statistical considerations for the platform trial in COVID-19 vaccine priming and boosting.

Michael Dymock, Charlie McLeod, Peter Richmond, Tom Snelling, Julie A Marsh, PICOBOO Investigator Team

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Michael DymockWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, 15 Hospital Avenue, Nedlands, 6009, Perth, Australia. michael.dymock@telethonkids.org.au.ORCID http://orcid.org/0000-0003-4881-2860
Charlie McLeodWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, 15 Hospital Avenue, Nedlands, 6009, Perth, Australia.
Peter RichmondWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, 15 Hospital Avenue, Nedlands, 6009, Perth, Australia.
Tom SnellingSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Camperdown, 2006, Sydney, Australia.
Julie A MarshWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, 15 Hospital Avenue, Nedlands, 6009, Perth, Australia.
PICOBOO Investigator Team

Funding

National Health and Medical Research Council 2014690National Health and Medical Research Council 2016473
6 · The paper itself

Abstract

The Platform trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, adaptive platform trial designed to generate evidence of the immunogenicity, reactogenicity, and cross-protection of different booster vaccination strategies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants, specific for the Australian context. The PICOBOO trial randomises participants to receive one of three COVID-19 booster vaccine brands (Pfizer, Moderna, Novavax) available for use in Australia, where the vaccine brand subtypes vary over time according to the national vaccine roll out strategy, and employs a Bayesian hierarchical modelling approach to efficiently borrow information across consecutive booster doses, age groups and vaccine brand subtypes. Here, we briefly describe the PICOBOO trial structure and report the statistical considerations for the estimands, statistical models and decision making for trial adaptations. This paper should be read in conjunction with the PICOBOO Core Protocol and PICOBOO Sub-Study Protocol 1: Booster Vaccination. PICOBOO was registered on 10 February 2022 with the Australian and New Zealand Clinical Trials Registry ACTRN12622000238774.

Indexed as

Bayes TheoremCOVID-19COVID-19 VaccinesImmunization, SecondarySARS-CoV-2Adaptive Clinical Trials as TopicAustraliaHumansImmunogenicity, VaccineModels, StatisticalMulticenter Studies as TopicRandomized Controlled Trials as TopicCOVID-19 VaccinesAdaptive trialBayesianCOVID-19ImmunogenicityReactogenicityVaccine

Identifiers

PMID39060943
PMCPMC11282703

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.