Evaluation of Adjuvanted Pandemic H1N12009 Influenza Vaccine After One and Two Doses in Young Children
Bibliographic record
Abstract
BACKGROUND: When Canada chose an adjuvanted influenza A H1N1(2009) vaccine for pandemic control, dosing requirements and safety in children were unknown. This study compared responses after 1 and 2 doses in young children. METHODS: Five Canadian centers evaluated ASO3-adjuvanted H1N1(2009) vaccine (Arepanrix, GSK Laval, Quebec) in children aged 6 to 35 months, given 2 doses (0.25 mL, 1.9 μg hemagglutinin) 21 days apart. Blood was collected at baseline and 21 to 28 days after each dose to measure hemagglutination inhibition antibody titers. Adverse events were documented daily for 7 days after each dose. RESULTS: Centers enrolled 167 children (mean age, 19 months). At baseline, 29 children (17.4%) had hemagglutination inhibition titers ≥ 10. After dose 1, titers ≥ 40 were present in 79.7% of initially naive subjects and 100% of initially primed subjects, whose respective geometric mean titers were 68 and 1020 (P < 0.001). After dose 2, 100% of subjects had titers ≥ 40, with geometric mean titers increasing to 723 in naive subjects and to 1854 in primed subjects (P < 0.001). Injection site reactions occurred in 56% of subjects after dose 1 and 43% after dose 2 (P < 0.01), with severe reactions noted in ≤ 3%. Fever >39.0°C was infrequent after either dose (5.4%, 6.6%, P = 0.20). Mild or moderate general symptoms were common but short-lived and less frequent after dose 2. CONCLUSIONS: One dose of adjuvanted vaccine met criteria for licensing seasonal influenza vaccines. A second dose increased titers substantially, potentially affording greater or more durable protection. Adverse effects were common but tolerable. The use of adjuvanted seasonal influenza vaccines in young children merits consideration.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".