Evidence map›Paper›PMID 40098448›Full record

ArticleHuman vaccines & immunotherapeutics2025

Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season.

Marina Amaral de Avila Machado, Sophie Gallo, Alexander Goldstein, Parth Vachhani, Reddappa Maniganahally Byrareddy, Anu Kantele, Hanna Välimaa, Jörg Schelling

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06059456 (Enhanced Passive Safety Surveillance of VaxigripTetra®), which is not on this 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.

NCT06059456 completednot on this map

Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High Dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2023/24

TypeobservationalSponsorSanofiRan2023 to 2023Enrolled2,078ConditionsInfluenza Immunization (Healthy Volunteers)ArmsQuadrivalent Influenza Vaccine, High-Dose Quadrivalent Influenza Vaccine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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.

Marina Amaral de Avila MachadoEpidemiology & Benefit-Risk, Sanofi, Toronto, Canada.ORCID 0000-0002-9625-0340
Sophie GalloMedical Operations, Sanofi, Lyon, France.
Alexander GoldsteinPatient Safety & Pharmacovigilance, Sanofi, Moscow, Russia.
Parth VachhaniPatient Safety & Pharmacovigilance, Sanofi, Bengaluru, India.
Reddappa Maniganahally ByrareddyPatient Safety & Pharmacovigilance, Sanofi, Bengaluru, India.
Anu KanteleMeilahti Vaccine Research Center MeVac, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Hanna VälimaaMeilahti Vaccine Research Center MeVac, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Jörg SchellingHausärztliche Gemeinschaftspraxis Martinsried, Martinsried, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Enhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023-24 season. The primary objective was to evaluate adverse drug reactions (ADRs) occurring ≤7 days following IIV4 vaccination. Enrolled participants were vaccinated in routine clinical care settings and encouraged to report ADRs. Exposure data and ADR reports were collected in a near real-time manner using an electronic system. Vaccinee reporting rate (RR) with 95% confidence interval (CI) was calculated as the number of vaccinees reporting ≥ 1 ADR divided by total number of vaccinees. In Finland for SD-IIV4, among 1,003 vaccinees aged ≥ 6 months, 81 reported a total of 192 suspected ADRs occurring ≤ 7 days following vaccination (vaccinee RR 8.08%; 95% CI 6.46, 9.94). In Germany for HD-IIV4, among 1,075 vaccinees aged ≥ 60 years, 15 reported 46 ADRs that occurred in ≤ 7 days of vaccination (vaccinee RR 1.40%; 95% CI 0.78, 2.29). No safety signal was detected during this surveillance. The 2023-24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4.

Indexed as

Drug-Related Side Effects and Adverse ReactionsInfluenza, HumanInfluenza VaccinesAdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overChildChild, PreschoolFemaleFinlandGermanyHumansInfantMaleInfluenza VaccinesVaccines, Inactivatedadverse drug reactionsEflueldaenhanced safety surveillanceinfluenza vaccinequadrivalent split-virion inactivated influenza vaccineVaxigrip Tetra

Identifiers

PMID40098448
PMCPMC12934124

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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.