What type of study is this?

September 20, 2025

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

Key Points

Key findings show no significant difference in vaccine effectiveness among the three types of influenza vaccines.
Among 15,432 participants, influenza was confirmed in 1.7% of cell-culture-based vaccine recipients and 1.3% of egg-based recipients.
This randomized trial assessed influenza vaccine effectiveness over three seasons and included immunogenicity assessment.
While VE estimates were similar, notable immunogenicity differences suggest potential benefits of non-egg-based vaccines.

Abstract

Abstract Background Influenza 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 two licensed influenza vaccines (cell-culture-based inactivated influenza vaccine (ccIIV) and recombinant influenza vaccine (RIV)) to egg-based inactivated influenza vaccine (eIIV). Methods Between 2018-2021, PAIVED randomized (1:1:1) eligible Military Health System (MHS) 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. Results Among 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%; p0.001 for all). ccIIV (N=357) recipients were more likely to seroconvert only against A/H3N2 compared to eIIV recipients (44.0% vs 30.4%) (p0.001). Conclusions Significant 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 Registration ClinicalTrials.gov NCT03734237

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Cite This Study

Colombo et al. (Thu,) studied this question.

synapsesocial.com/papers/68d46fc631b076d99fa69a84 https://doi.org/https://doi.org/10.1093/cid/ciaf503

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