Evidence map›Paper›PMID 39702896›Full record

Trial reportInfluenza and other respiratory viruses2024

Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18-64 and ≥65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial.

Andrew Hastie, Tanya Clarke, Sophie Germain, Thierry Ollinger, Patricia Lese, Vinay Gupta

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Influenza and other respiratory viruses, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04789577 (A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Hong Kong/125/2017-like), 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.

NCT04789577 phase2completednot on this map

A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Hong Kong/125/2017-like (H7N9) Virus Vaccine With AS03 Adjuvant System, Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2022Enrolled833ConditionsInfluenza, HumanArmsFLU-Q-PAN H7N9 Formulation 1, FLU-Q-PAN H7N9 Formulation 2, FLU-Q-PAN H7N9 Formulation 3, AS03B, AS03A
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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.

Andrew HastieGSK, Rockville, Maryland, USA.
Tanya ClarkeGSK, Rockville, Maryland, USA.
Sophie GermainGSK, Wavre, Belgium.
Thierry OllingerGSK, Wavre, Belgium.
Patricia LeseGSK, Rockville, Maryland, USA.
Vinay GuptaGSK, Bangalore, India.

Funding

GSKUS Department of Health and Human Services HHSO100201600004I
6 · The paper itself

Abstract

backgroundInfluenza A/Hong Kong/125/2017 (H7N9) virus poses a pandemic risk owing to its evolving nature. This study evaluated the immunogenicity and safety of an AS03-adjuvanted H7N9 vaccine in adults (18-64 years [younger] and ≥65 years [older]).

methodsParticipants (younger, n = 418; older, n = 420) were randomized to receive one of six adjuvanted vaccines (hemagglutinin [1.9 μg, 3.75 μg, and 7.5 μg] with AS03

resultsH7N9 AS03-adjuvanted vaccines at various doses showed a humoral immune response but failed to meet CBER immunogenicity criteria. However, a trend of increased immune responses was observed with the AS03

conclusionsThis study did not achieve its primary objective at any dose level. The modest immune response to AS03-adjuvanted vaccines, consistent with other studies using similar antigens, highlights the need for continued research for H7N9 pandemic preparedness.

trial registrationNCT04789577 [ClinicalTrials.gov].

Indexed as

Antibodies, ViralInfluenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza VaccinesAdjuvants, ImmunologicAdjuvants, VaccineAdolescentAdultAgedalpha-TocopherolDouble-Blind MethodDrug CombinationsFemaleHumansImmunogenicity, VaccineMaleAdjuvants, ImmunologicAdjuvants, Vaccinealpha-TocopherolAntibodies, ViralAS03 adjuvantDrug CombinationsInfluenza VaccinesPolysorbatesSqualeneAS03H7N9influenzavaccine

Identifiers

PMID39702896
PMCPMC11658966

What OpenQuestion holds

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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.