160. Safety and Immunogenicity of Escalating Dose Formulations of High-dose Quadrivalent Influenza Vaccine in Children 6 Months Through < 18 Years of Age
Notice bibliographique
Résumé
Abstract Background Children do not respond immunologically as well as adults to standard-dose (SD) influenza vaccination and remain at increased risk of influenza and its complications. A method to improve efficacy in children may be to increase antigen amount per dose, a successful strategy used in older adults. Trivalent high-dose (HD) influenza vaccine (60ug hemagglutinin/strain) showed significantly improved effectiveness for prevention of clinical outcomes related to influenza in adults ≥65 years; moreover, a quadrivalent HD formulation was approved by US FDA (2019) for use in this group. Methods A Phase 2, randomized, modified double blind study (NCT03698279) was conducted in US and Canadian children to evaluate safety and immunogenicity of IIV4-HD compared to an IIV4-SD and adjuvanted trivalent influenza vaccine (aIIV3). Children (n=661, 6 months through < 18 years) were assigned to receive intramuscularly 1 of 3 formulations of IIV4-HD (30, 45, or 60 µg HA/strain/dose), a licensed IIV4-SD, or a licensed aIIV3. Depending on child’s previous influenza vaccination status and age, they received 1 or 2 doses of study vaccine 28 days apart. Post-vaccination (28 days after each vaccination) geometric mean titers (GMTs) and seroconversion rates were measured using hemagglutinin inhibition (HAI) assay. Reactogenicity data were collected through 1 week; safety data were collected through 6 months post-vaccination. Results IIV4-HD was more reactogenic than IIV4-SD, but unsolicited related adverse events were similar (Table 1). No related serious adverse events or deaths occurred. A dose-related increase in HAI GMT ratio was observed across the age range for A/H3N2 but only in children 6 months through < 3 years for A/H1N1 and the 2 B strains (Table 2). Compared with IIV4-SD, the 60 µg HA/strain/dose formulation of IIV4-HD generated highest HAI GMT ratios and high seroconversion rates for all 4 strains in US children 6 months through < 3 years. Canadian children receiving IIV4-HD generated HAI titers incongruent to those of US children receiving IIV4-HD, limiting direct comparison against aIIV3. Safety Overview (US and Canadian subjects 6 months through <18 years) HAI GMT Ratios (QIV-HD/QIV-SD) at 28 days After the Last Vaccination (US subjects 6 months through <18 years) Conclusion The favorable safety profile and the HAI GMT ratios support pediatric dose selection of 60µg HA/strain/dose as most appropriate to evaluate in Phase 3. Disclosures Leejah Chang, MD, Sanofi Pasteur (Employee) Evan J. Anderson, MD, Sanofi Pasteur (Scientific Research Study Investigator) Robert Jeanfreau, MD, Sanofi Pasteur (Scientific Research Study Investigator) Ying He, PhD, Otsuka Pharmaceutical (Employee)Sanofi Pasteur (Other Financial or Material Support, Former employee) Bryony Hicks, BSc, Sanofi Pasteur (Employee) Anju Shrestha, MD, Sanofi Pasteur (Employee) Aseem Pandey, PhD, Sanofi Pasteur (Employee)Sanofi Pasteur (Employee) Rawia Khoury, BSc, Sanofi Pasteur (Employee) Iris De Bruijn, PhD, Sanofi Pasteur (Employee) Victoria Landolfi, MS, MBA, Sanofi Pasteur (Employee)
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».