Evidence map›Paper›PMID 29148911›Full record

Observational studyHuman vaccines & immunotherapeutics2018

Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season.

Anne Laure Chabanon, Hélène Bricout, Céline Ballandras, Audrey Souverain, Timothy David Caroe, Karina M Butler

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

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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.

Anne Laure Chabanona Sanofi Pasteur , Lyon , France.
Hélène Bricouta Sanofi Pasteur , Lyon , France.
Céline Ballandrasb Sanofi Pasteur MSD , Lyon , France.
Audrey Souverainc Aixial, Boulogne-Billancourt, France.
Timothy David Caroed Lighthouse Medical Practice , Eastbourne , East Sussex , UK.
Karina M Butlere Our Lady's Children's Hospital Crumlin , Dublin , Republic of Ireland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15 µg. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15 µg (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15 µg only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.

Indexed as

Product Surveillance, PostmarketingAdolescentAdultAgedChildChild, PreschoolHumansInfantInfant, NewbornInfluenza, HumanInfluenza VaccinesIrelandMiddle AgedUnited KingdomVaccinationInfluenza VaccinesInactivated influenza vaccineinfluenzapassive surveillanceThe Republic of IrelandUnited Kingdomvaccines and immunization

Identifiers

PMID29148911
PMCPMC5806654

What OpenQuestion holds

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LicenceCC BY
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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.