Evidence map›Paper›PMID 40907068›Full record

ReviewVaccine2025

Adopting the estimand framework in prophylactic vaccine trials.

Francois Beckers, Naveen Karkada, Ye Yang, John Scott, Lei Huang, Florian Klinglmüller, Michael P Fay, Stefan Englert, Bart Spiessens, Ilse Van Dromme and 6 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Francois BeckersSanofi, Marcy-l'Étoile, France. Electronic address: francois.beckers@sanofi.com.
Naveen KarkadaGlaxoSmithKline, Rixensart, Belgium.
Ye YangCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
John ScottCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Lei HuangCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Florian KlinglmüllerAustrian Agency for Health and Food Safety, Vienna, Austria.
Michael P FayNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, USA.
Stefan EnglertJohnson & Johnson, Neuss, Germany.
Bart SpiessensJohnson & Johnson, Beerse, Belgium.
Ilse Van DrommeJohnson & Johnson, Beerse, Belgium.
Tulin ShekarMerck & Co. Inc, Rahway, NJ, USA.
Honghong ZhouModerna Inc, Cambridge, MA, USA.
Qiqi DengModerna Inc, Cambridge, MA, USA.
Daniela CasulaCSL Seqirus, Siena, Tuscany, Italy.
Holly JanesFred Hutchinson Cancer Center, Seattle, Washington.
Lawrence H MoultonPfizer Canada, Kirkland, Quebec, Canada.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The estimand framework as outlined in ICH E9(R1) has been extensively discussed and implemented in clinical trials of therapeutic products. However, there is limited literature on the application of the framework in preventive vaccine trials, which has many unique characteristics, including emphasis on estimating the per-protocol or "biological" effect. We provide a comprehensive review of the application of the framework to preventive vaccine trials evaluating clinical outcome and immunogenicity, focusing on commonly encountered intercurrent events including but not limited to: noncompliance with vaccination schedule and blood sampling window, infection not meeting protocol definition, death, and use of prohibited products. We discuss various considerations in choosing strategies to handle intercurrent events in terms of their utility in addressing the scientific questions. Finally, we provide considerations and examples for summarizing study estimands and data handling which may be incorporated into the protocol and statistical analysis plan.

Indexed as

Clinical Trials as TopicVaccinesHumansImmunization ScheduleResearch DesignVaccinationVaccinesEstimandICH E9(R1)Vaccine

Identifiers

PMID40907068
PMCPMC12433591

What OpenQuestion holds

Textmetadata
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.