Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through <18 years of age: A randomized controlled phase II dose-finding trial
Bibliographic record
Abstract
Quadrivalent high-dose inactivated influenza vaccine (Fluzone® High-Dose Quadrivalent, IIV4-HD) was licensed in the USA in 2019 for adults ≥ 65 years of age. This Phase II study examined safety and immunogenicity of 3 dose formulations of IIV4-HD in healthy children. In a randomized, modified double-blind, active-controlled trial in the USA and Canada, 661 children aged 6 months through < 18 years received 1 or 2 doses intramuscularly of standard-dose quadrivalent influenza vaccine (IIV4-SD; 15 µg HA/strain), IIV4-HD at 3 dose levels (30, 45, and 60 µg HA/strain), or adjuvanted trivalent influenza vaccine (aIIV3, 7.5 µg HA/strain). Rates of unsolicited AEs were similar irrespective of dose. No treatment-related serious adverse events or deaths were reported. Reactogenicity was slightly higher for IIV4-HD than IIV4-SD, although most solicited reactions were grade 1 or 2. Hemagglutination inhibition (HAI) and seroneutralization antibody titers were measured 28-35 days after each dose. Geometric mean HAI titers increased with increasing hemagglutinin dose, especially in children 6 months through < 3 years. For IIV4-HD 60 µg, in participants 6 months through < 18 years of age, the geometric mean titer ratio (95% confidence interval) versus IIV4-SD was 1.35 (0.94, 1.94) for A/H1N1, 2.51 (1.77, 3.55) for A/H3N2, 1.60 (1.17, 2.18) for B/Victoria, and 1.51 (1.13, 2.03) for B/Yamagata. The GMT ratio (95% confidence interval) for IIV4-HD 60 µg versus IIV4-SD was highest for participants 6 months through < 3 years of age: 4.24 (2.05, 8.76) for A/H1N1, 3.14 (1.53, 6.44) for A/H3N2, 2.04 (1.10, 3.77) for B/Victoria, and 1.92 (1.08, 3.41) for B/Yamagata; similarly, seroneutralization antibody GMT ratio was highest in these participants: 170 (84.6, 340) for A/H1N1, 7.13 (4.90, 10.4) for A/H3N2, 35.8 (22.1, 58.1) for B/Victoria, and 22.7 (14.7, 35.0) for B/Yamagata. This study showed that IIV4-HD (60 µg HA/strain) provides improved immunogenicity without affecting vaccine safety in children.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".