Evidence map›Paper›PMID 28925801›Full record

Trial reportHuman vaccines & immunotherapeutics2018

MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico.

Aurelio Cruz-Valdez, Gabriel Valdez-Zapata, Sanjay S Patel, Flavia V Castelli, Marcia G Garcia, Wim T Jansen, Ashwani Kumar Arora, Esther Heijnen

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 13% of its field
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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Therapeutic peptides and proteins: Status and developments in drug delivery.Journal of controlled release : official journal of the Controlled Release Society · 2026
    Review
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  9. Article
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  12. Lipid-based regulators of immunity.Bioengineering & translational medicine · 2022
    Review
  13. Article
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  15. Observational
  16. Article
  17. Immunological dynamics after subcutaneous immunization with a squalene-based oil-in-water adjuvant.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2020
    Article
  18. Review
  19. 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

8 authors at 5 institutions in 5 countries.

Aurelio Cruz-Valdeza Center of Investigation of Public Health, National Institute of Public Health , Cuernavaca , Morelos , México.
Gabriel Valdez-Zapatab Department of Pediatric Investigation , UNAMIS , Mérida , Yucatán , México.
Sanjay S Patelc Influenza Vaccines Development, Novartis Influenza Vaccines , Cambridge , MA , USA.
Flavia V Castellid Vaccines R&D, GSK , Bs.As. , Argentina.
Marcia G Garciae Vaccines R&D, GSK , Mexico City , México.
Wim T Jansenf Department of BioStatistics GSK , Amsterdam , The Netherlands.
Ashwani Kumar Arorag Clinical Development, Novartis Vaccines , Siena , Italy.
Esther Heijnenh Seasonal Influenza Vaccines, Seqirus , Amsterdam , The Netherlands.
Autonomous University of Yucatán · MXGGD Amsterdam · NLGlobal Vaccines (United States) · USNational Institute of Public Health · SINovartis (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during the 2014-2015 season. The primary objectives were to assess the non-inferiority of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV and TIV. Seroconversion was one of several secondary objectives. In total, 287 children were enrolled. The non-inferiority criteria for GMTs and seroconversion were met for aTIV for all 3 vaccine strains. Lower bounds of the 95% confidence intervals for all 3 aTIV:TIV vaccine ratios were >2, showing that the immunogenicity of aTIV was superior to that of TIV for all 3 strains. Solicited adverse events (AEs) were experienced more frequently with aTIV than TIV by younger children (aged 6 to <36 months), but were more frequent with TIV than aTIV in older children (aged 36 to <72 months) who had been vaccinated previously. More unsolicited AEs were associated with aTIV than the TIV. All AEs were of mild or moderate severity. No deaths, serious AEs, or AEs leading to premature withdrawal were reported. Overall, aTIV was highly immunogenic and was well tolerated in healthy children 6 to <72 months of age. These results indicate that aTIV may be a beneficial addition to national pediatric vaccination programs.

Indexed as

Adjuvants, ImmunologicChild, PreschoolFemaleHumansIndolesInfantInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusInfluenza, HumanInfluenza VaccinesMaleMexicoSulfonylurea CompoundsAdjuvants, ImmunologicIndolesInfluenza VaccinesMF 592Sulfonylurea CompoundsadjuvantimmunogenicityinfluenzaMF59safetytrivalent influenza vaccine

Identifiers

PMID28925801
PMCPMC5806633
OpenAlexW2755826838

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.