Evidence map›Paper›PMID 40973113›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Randomized Pragmatic Trial of the Comparative Effectiveness of Chicken Egg-Based Inactivated, Mammalian Cell Culture-Based Inactivated, and Recombinant Protein Quadrivalent Seasonal Influenza Vaccines in United States Military Health System Beneficiaries.

Rhonda E Colombo, Stephanie A Richard, Kat Schmidt, Christina Schofield, Anuradha Ganesan, Wesley Campbell, David Hrncir, Tahaniyat Lalani, Katrin Mende, Ana E Markelz and 23 more

Registry-linked trialAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03734237 (A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03734237 phase4active not recruitingnot on this map

A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

TypeinterventionalSponsorHenry M. Jackson Foundation for the Advancement of Military MedicineRan2018 to 2026Enrolled15,448ConditionsInfluenza, Influenza-like Illness, Influenza VaccinesArmsEgg based influenza vaccines, Recombinant influenza vaccines, Cell-culture based influenza vaccines
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. 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

33 authors.

Rhonda E ColomboInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.ORCID 0000-0003-0154-1928
Stephanie A RichardInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.ORCID 0000-0002-0530-384X
Kat SchmidtInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Christina SchofieldDepartment of Medicine, Madigan Army Medical Center, Tacoma, Washington, USA.ORCID 0000-0002-4412-2611
Anuradha GanesanInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Wesley CampbellDepartment of Medicine, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.
David HrncirCarl R. Darnall Army Medical Center, Fort Cavazos, Texas, USA.
Tahaniyat LalaniInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.ORCID 0000-0002-9361-2991
Katrin MendeInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Ana E MarkelzDepartment of Medicine, Brooke Army Medical Center, San Antonio, Texas, USA.ORCID 0009-0006-4473-3902
Catherine M BerjohnInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Laurie HouselImmunization Healthcare Division, Defense Health Agency, Falls Church, Virginia, USA.ORCID 0009-0007-5999-8935
Dorothy BecherInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Elizabeth R ZellStat-Epi Associates, Inc, Ponte Vedra Beach, Florida, USA.
Daniel EwingViral Diseases Program, Naval Medical Research Command, Silver Spring, Maryland, USA.
Appavu K SundaramViral Diseases Program, Naval Medical Research Command, Silver Spring, Maryland, USA.
Jitendrakumar R ModiNavy Medicine Readiness and Training Command, Annapolis, Maryland, USA.
Adam SapersteinDepartment of Family Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.ORCID 0000-0003-1628-3490
Drake H TilleyNavy Medicine Readiness and Training Command, Annapolis, Maryland, USA.
Alan WilliamsDepartment of Family Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.ORCID 0000-0003-1386-0547
Bruce McClenathanImmunization Healthcare Division, Defense Health Agency, Falls Church, Virginia, USA.ORCID 0009-0009-6717-667X
Limone CollinsImmunization Healthcare Division, Defense Health Agency, Falls Church, Virginia, USA.
Christina SpoonerImmunization Healthcare Division, Defense Health Agency, Falls Church, Virginia, USA.
Srihari SeshadriImmunization Healthcare Division, Defense Health Agency, Falls Church, Virginia, USA.ORCID 0000-0002-0540-4843
Anthony FriesPublic Health and Preventive Medicine Department, US Air Force School of Aerospace Medicine, Wright-Patterson AFB, Ohio, USA.ORCID 0000-0001-7556-1353
Ryan C MavesDepartment of Medicine, Naval Medical Center San Diego, San Diego, California, USA.
John H Powers IiiClinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.ORCID 0000-0002-5150-5119
Robert J O'ConnellInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.ORCID 0000-0001-8901-1432
Simon D PollettInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Mark P SimonsInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
Christian L ColesInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.ORCID 0009-0006-2573-0706
Timothy H BurgessInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
PAIVED Study Group

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
Defense Health Agency Immunization Healthcare Division HU0001190002Defense Health ProgramDepartment of DefenseInfectious Disease Clinical Research ProgramInter-Agency Y1-Al-5072National Institute of Allergy and Infectious DiseasesNational Institutes of Health Clinical CenterNCI NIH HHS 75N91019D00024NIH HHS 75N91019D00024NIH HHS 75N91019F00130Uniformed Services University of the Health SciencesUS Department of Defense
6 · The paper itself

Abstract

backgroundInfluenza is a major cause of morbidity and mortality worldwide. The Pragmatic Assessment of Influenza Vaccine Effectiveness (VE) in the Department of Defense (PAIVED) study compared the relative VE (rVE) of 2 licensed influenza vaccines (cell culture-based inactivated influenza vaccine [ccIIV] and recombinant influenza vaccine [RIV]) to egg-based inactivated influenza vaccine (eIIV).

methodsBetween 2018 and 2021, PAIVED randomized (1:1:1) eligible Military Health System beneficiaries to receive eIIV, ccIIV, or RIV during an influenza season. Participants received weekly surveys querying influenza-like illness (ILI); those reporting ILI completed an online symptom diary, were interviewed by research staff, and underwent nasal swab collection. Laboratory-confirmed influenza was the primary outcome. Immunogenicity assessment was conducted in a subset of participants.

resultsAmong 15 432 participants, influenza was identified in 87/5130 (1.7%) ccIIV recipients, 79/5154 (1.5%) RIV recipients, and 69/5148 (1.3%) eIIV recipients during their season of enrollment. rVE of ccIIV compared to eIIV was -27% (95% confidence interval [CI], -73%, 8%), and rVE of RIV compared to eIIV was -14% (95% CI -58%, 17%). RIV (N = 375) recipients were more likely to seroconvert (4-fold increase) than those who received eIIV (N = 355) (A/H1N1: 49.1% vs 29.0%; A/H3N2: 71.2% vs 30.4%; B/Victoria 24.5% vs 13.8%; B/Yamagata 17.1% vs 5.4%; P < .001 for all). ccIIV (N = 357) recipients were more likely to seroconvert only against A/H3N2 compared with eIIV recipients (44.0% vs 30.4%) (P < .001).

conclusionsSignificant differences in VE were not detected comparing egg-based to non-egg-based influenza vaccines, although immunogenicity differences were observed; low influenza case numbers impacted VE estimate precision.

trial registrationClinicalTrials.gov NCT03734237.

Indexed as

Influenza, HumanInfluenza VaccinesVaccine EfficacyAdolescentAdultAnimalsChickensEggsFemaleHumansInfluenza A Virus, H1N1 SubtypeMaleMiddle AgedMilitary HealthMilitary PersonnelRecombinant ProteinsInfluenza VaccinesRecombinant ProteinsVaccines, InactivatedVaccines, Syntheticimmunogenicityinfluenzainfluenza-like illnesssymptomsvaccine

Identifiers

PMID40973113
PMCPMC12728286

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.