Evidence map›Paper›PMID 39803784›Full record

Trial reportHuman vaccines & immunotherapeutics2025

Safety and immunogenicity of a bivalent norovirus vaccine candidate in infants from 6 weeks to 5 months of age: A phase 2, randomized, double-blind trial.

Xavier Sáez-Llorens, Rodrigo deAntonio, Eduardo López-Medina, Pío López, Taisei Masuda, Paul M Mendelman, Jim Sherwood, Frank Baehner, Astrid Borkowski

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Chemical reviews · 2026
    Review
  2. Article
  3. Harnessing Nanocarriers to Advance Vaccine Development.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. Review
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

9 authors.

Xavier Sáez-LlorensCevaxin, The Panama Clinic, Panama City, Panama.
Rodrigo deAntonioCevaxin, The Panama Clinic, Panama City, Panama.
Eduardo López-MedinaCentro de Estudios en Infectología Pediátrica S.A.S, Cali, Valle del Cauca, Colombia.
Pío LópezCentro de Estudios en Infectología Pediátrica S.A.S, Cali, Valle del Cauca, Colombia.
Taisei MasudaClinical Development, Takeda Pharmaceuticals International AG, Zurich, Switzerland.
Paul M MendelmanClinical Development, Takeda Vaccines Inc, Cambridge, MA, USA.
Jim SherwoodClinical Development, Takeda Pharmaceuticals International AG, Zurich, Switzerland.
Frank BaehnerClinical Development, Takeda Pharmaceuticals International AG, Zurich, Switzerland.
Astrid BorkowskiClinical Development, Takeda Pharmaceuticals International AG, Zurich, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As infants suffer significant morbidity and mortality due to norovirus-related acute gastroenteritis (AGE), we assessed four formulations of the bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in Panamanian and Colombian infants. 360 infants aged 6 weeks to 5 months were randomly allocated to 8 groups to receive three doses of HIL-214 or two doses of HIL-214 and one dose of placebo (Days 1, 56 and 112), where HIL-214 doses contained 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH)

Indexed as

Caliciviridae InfectionsGastroenteritisImmunogenicity, VaccineNorovirusVaccines, Virus-Like ParticleViral VaccinesAntibodies, ViralColombiaDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfantMalePlacebosAntibodies, ViralPlacebosVaccines, Virus-Like ParticleViral VaccinesimmunogenicityinfantsNorovirusreactogenicityvaccinevirus-like particles

Identifiers

PMID39803784
PMCPMC11730628

What OpenQuestion holds

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LicenceCC BY-NC
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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.