Evidence map›Paper›PMID 21915319›Full record

SynthesisPloS one2011

Meta-analysis of the immunogenicity and tolerability of pandemic influenza A 2009 (H1N1) vaccines.

Lamberto Manzoli, Corrado De Vito, Georgia Salanti, Maddalena D'Addario, Paolo Villari, John P A Ioannidis

Open access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 15 pooled it
6.2field-weighted citation impact, top 3% 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

44 citing papers in PubMed, 15 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Pooled it
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  3. Interventions to prevent preterm birth following fetoscopic laser surgery for twin-to-twin transfusion syndrome: systematic review and meta-analysis.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2025
    Pooled it
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  5. Efficacy and mortality of rotating sheaths versus laser sheaths for transvenous lead extraction: a meta-analysis.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023
    Pooled it
  6. Monkeypox infection in pregnancy: a systematic review and metaanalysis.American journal of obstetrics & gynecology MFM · 2023
    Pooled it
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  8. Vaccines for preventing influenza in healthy children.The Cochrane database of systematic reviews · 2018
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  9. Industry sponsorship and research outcome.The Cochrane database of systematic reviews · 2017
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  14. Vaccines for preventing influenza in healthy children.The Cochrane database of systematic reviews · 2012
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  16. Trial
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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 at 3 institutions in 3 countries.

Lamberto ManzoliSection of Hygiene, Epidemiology, Pharmacology and Legal Medicine, University G. d'Annunzio of Chieti, Chieti, Italy. lmanzoli@post.harvard.edu
Corrado De Vito
Georgia Salanti
Maddalena D'Addario
Paolo Villari
John P A Ioannidis
Sapienza University of Rome · ITUniversity of Ioannina · GRUniversity of Chieti-Pescara · IT

Funding

European Research Council 260559
6 · The paper itself

Abstract

backgroundAlthough the 2009 (H1N1) influenza pandemic officially ended in August 2010, the virus will probably circulate in future years. Several types of H1N1 vaccines have been tested including various dosages and adjuvants, and meta-analysis is needed to identify the best formulation.

methodsWe searched MEDLINE, EMBASE, and nine clinical trial registries to April 2011, in any language for randomized clinical trials (RCTs) on healthy children, adolescents, adults and the elderly. Primary outcome was the seroconversion rate according to hemagglutinination-inhibition (HI); secondary outcomes were adverse events. For the primary outcome, we used head-to-head meta-analysis and multiple-treatments meta-analysis.

resultsEighteen RCTs could be included in all primary analyses, for a total of 76 arms (16,725 subjects). After 2 doses, all 2009 H1N1 split/subunit inactivated vaccines were highly immunogenic and overcome CPMP seroconversion criteria. After 1 dose only, all split/subunit vaccines induced a satisfactory immunogenicity (> = 70%) in adults and adolescents, while only some formulations showed acceptable results for children and elderly (non-adjuvanted at high-doses and oil-in-water adjuvanted vaccines). Vaccines with oil-in-water adjuvants were more immunogenic than both nonadjuvanted and aluminum-adjuvanted vaccines at equal doses and their immunogenicity at doses < = 6 µg (even with as little as 1.875 µg of hemagglutinin antigen) was not significantly lower than that achieved after higher doses. Finally, the rate of serious vaccine-related adverse events was low for all 2009 H1N1 vaccines (3 cases, resolved in 10 days, out of 22826 vaccinated subjects). However, mild to moderate adverse reactions were more (and very) frequent for oil-in-water adjuvanted vaccines.

conclusionsSeveral one-dose formulations might be valid for future vaccines, but 2 doses may be needed for children, especially if a low-dose non-adjuvanted vaccine is used. Given that 15 RCTs were sponsored by vaccine manufacturers, future trials sponsored by non-industry agencies and comparing vaccines using different types of adjuvants are needed.

Indexed as

AdolescentAdultAgedChildChild, PreschoolFemaleHumansInfantInfluenza A Virus, H1N1 SubtypeInfluenza VaccinesMaleMiddle AgedRandomized Controlled Trials as TopicYoung AdultInfluenza Vaccines

Identifiers

PMID21915319
PMCPMC3167852
OpenAlexW1976093111

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.