| Primary | Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect. | Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or Microneutralization antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Fold change | | From Week 12 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
| | | Title | Denominators | Categories |
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| Influenza A H1N1 | | | Title | Measurements |
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| - OG0007.34± 1.361(1.361 to )
- OG0014.75± 1.455(1.455 to )
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| | Influenza B Yamagata Lineage | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model. | | | | | Geometric Least square (LS) mean ratio | 0.65 | | | 2-Sided | 90 | 0.43 | 0.98 | | | | | Other | | | | Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model |
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| Primary | Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. | Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Fold change | | From Week 12 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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| Primary | Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs) | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect. | Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Titer | | Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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| Primary | Post-vaccination Strain-specific Serum MN Antibody GMTs | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. | Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Titer | | Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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| Primary | Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect. | Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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| Primary | Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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| Primary | Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40 | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect. | Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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| Primary | Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40 | Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. | Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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| Secondary | Serum Tezepelumab Concentrations | Tezepelumab serum concentrations were summarized using descriptive statistics at each visit. | Pharmacokinetic (PK) analysis set consisted of all patients who received tezepelumab and from whom PK blood samples were obtained and assumed not to be affected by factors such as protocol deviations. Here, Number of patients analyzed in each row reflects number of patients analyzed for that timepoint | Posted | | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (μg/mL) | | Week 0, Week 12, Week 16 and Week 28 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS |
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| Secondary | Immunogenicity | Immunogenicity assessments were performed. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA. | Safety analysis set consisted of all patients who received at least 1 dose of study intervention. | Posted | | Number | | Patients | | From Baseline to Week 28 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS | | OG001 | Placebo | Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS |
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