scholarly journals 6. MF59 ASSURANCE 2: A Real-world Study to Estimate the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-based Trivalent High-dose Among U.S. Older Adults During 2018–19 Influenza Season

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S3-S3
Author(s):  
Stephen I Pelton ◽  
Maarten Postma ◽  
Victoria Divino ◽  
Drishti Shah ◽  
Joaquin F Mould-Quevedo ◽  
...  
Keyword(s):  
Older Adults ◽  
Influenza Vaccine ◽  
Poisson Regression ◽  
Influenza Season ◽  
Cohort Analysis ◽  
Vaccine Effectiveness ◽  
High Dose ◽  
Office Visits ◽  
Research Support ◽  
Trivalent Influenza Vaccine

Abstract Background In the 2018–19 influenza season, influenza resulted in almost 280,000 hospitalizations and over 25,000 deaths in U.S. adults > 65 years. This study aimed to evaluate the relative vaccine effectiveness (rVE) of adjuvant trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD), against influenza-related hospitalizations/emergency room (ER) visits, office visits and hospitalization/ER visit for cardio-respiratory disease (CRD) among older adults for the 2018–19 flu season. Methods A retrospective cohort analysis of older adults (> 65 years) was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index (CCI), comorbidities, indicators of frail health status, and pre-index hospitalization rates. Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE against influenza-related hospitalizations/ER visits and office visits and any hospitalization/ER visit for CRD (based on diagnoses codes). An unrelated outcome, urinary tract infection (UTI) hospitalization, was assessed. Results During 2018–19 flu season, following IPTW analyses, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. After IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (6.6%; 95% CI: 2.8%-10.3%). aTIV was statistically comparable to TIV-HD (2.0%; 95% CI: -3.7%-7.3%) for prevention of influenza-related hospitalizations/ER visits but more effective than TIV-HD (2.6%; 95% CI: 2.0%-3.2%) in reducing hospitalizations/ER visits for CRD. No treatment effect was identified for control condition (UTI hospitalization). Conclusion In adjusted analyses, aTIV reduced influenza-related office visits and CRD hospitalizations/ER visits compared to TIV-HD. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits. Disclosures Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Maarten Postma, Dr., IQVIA (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)

scholarly journals 14. A Comprehensive Real-World Analysis to Compare Adjuvanted Trivalent Influenza Vaccine and Trivalent High Dose Influenza Vaccine by Age and Period of High Influenza Activity for the 2018–19 Season among U.S. Elderly

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S29-S30
Author(s):  
Maarten Postma ◽  
Stephen I Pelton ◽  
Victoria Divino ◽  
Joaquin F Mould-Quevedo ◽  
Drishti Shah ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Poisson Regression ◽  
Age Groups ◽  
Vaccine Effectiveness ◽  
High Dose ◽  
Office Visits ◽  
Research Support ◽  
Trivalent Influenza Vaccine ◽  
Influenza Activity ◽  
The U.S

Abstract Background Influenza vaccine effectiveness decreases with increasing age due to the senescence of immune function and a reduced immune response to antigens. There is also considerable vaccine effectiveness heterogeneity depending on the influenza activity time period, especially in seasons where two different circulating strains predominated, such as the 2018–19 season. This research aimed to assess the effect of age and high influenza activity period (HIAP) on the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) vs. trivalent high-dose influenza vaccine (HD-TIV) among elderly (≥65y) recipients in the U.S. Methods During the 2018–19 influenza season, a retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. The first sub-analysis evaluated rVE for different age groups (65–74 years, 75–84 years, ≥85 years). The second sub-analysis evaluated rVE overall, restricting the observation period from to HAIP: Dec 2018-Mar 2019 (August 2018-July 2019 in the main analysis). Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE for influenza-related hospitalizations/emergency room (ER) visits and office visits. Results Following IPTW, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. Following IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (7.0%; 95% CI: 2.6%-11.2%) in the HIAP sub-analysis. In the age sub-analysis, the rVE favoring aTIV ranged from 5.1% (95% CI: -0.17%-10.1%) for the youngest group (65–74) up to 11.4% (95% CI: 0.6%-21.1%) for the eldest group (≥85y) for influenza-related office visits. No statistically significant differences were found for aTIV compared to TIV-HD for prevention of influenza-related hospitalizations/ER visits in the sub-analyses evaluated. Conclusion In adjusted analyses, aTIV reduced influenza-related office visits compared to TIV-HD within the two older age groups and HIAP sub-analysis. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits. Disclosures Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant)

scholarly journals 25. Relative Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-Based Trivalent High-Dose Influenza Vaccine among U.S. Older Adults during 2019-20 Influenza Season

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S136-S136
Author(s):  
myron J levin ◽  
Victoria Divino ◽  
Stephen I Pelton ◽  
Maarten Postma ◽  
Drishti Shah ◽  
...  
Keyword(s):  
Older Adults ◽  
Influenza Vaccine ◽  
Poisson Regression ◽  
Influenza Season ◽  
Cohort Analysis ◽  
Relative Effectiveness ◽  
Geographic Region ◽  
Negative Control ◽  
High Dose ◽  
Trivalent Influenza Vaccine

Abstract Background According to the Centers for Disease Control and Prevention (CDC), during the 2019-20 U.S. influenza season, influenza resulted in almost 180,000 hospitalizations and over 13,000 deaths in adults ≥ 65 years. The current study evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD), against influenza-related hospitalizations/emergency room (ER) visits, all-cause hospitalizations and hospitalizations/ER visits for cardio-respiratory disease (CRD) among adults ≥65 years for the 2019-20 influenza season. Methods A retrospective cohort analysis of older adults (≥ 65 years) was conducted using IQVIA’s professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, geographic region, Charlson Comorbidity Index (CCI), comorbidities, indicators of frail health status, and pre-index hospitalization rates. To avoid any influenza outcome misclassification with COVID-19 infection, the study period ended March 7, 2020. Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE against influenza-related hospitalizations/ER visits, all-cause hospitalizations and any hospitalization/ER visit for CRD. An unrelated negative control outcome, urinary tract infection (UTI) hospitalization was included. Results During the 2019-20 influenza season, following IPTW, 798,987 recipients of aTIV and 1,655,979 recipients of TIV-HD were identified. After IPTW adjustment and Poisson regression, aTIV was statistically comparable to TIV-HD for prevention of influenza-related hospitalizations/ER visits (3.1%; 95% CI: -2.8%-8.6%) and all-cause hospitalizations (-0.7%; 95% CI: -1.6%-0.3%). Similar comparable outcomes were found for reduction of any hospitalization/ER visit for CRD (0.9%; 95% CI: 0.0%-1.7%). No treatment effect was identified for the negative control outcome. Conclusion aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits, all-cause hospitalizations and hospitalizations/ER visits for CRD. Disclosures myron J. levin, MD, GSK group of companies (Employee, Research Grant or Support) Victoria Divino, PhD, Seqirus (Consultant) Stephen I. Pelton, MD, Seqirus (Consultant) Maarten Postma, Dr., Seqirus (Consultant) Drishti Shah, PhD, Seqirus (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus (Employee) Mitchell DeKoven, PhD, Seqirus (Consultant)

scholarly journals Evaluating the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to High-Dose Trivalent and Other Egg-Based Influenza Vaccines among Older Adults in the US during the 2017–2018 Influenza Season

Vaccines ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 446
Author(s):  
Stephen I. Pelton ◽  
Victoria Divino ◽  
Drishti Shah ◽  
Joaquin Mould-Quevedo ◽  
Mitch DeKoven ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Influenza Season ◽  
Cohort Analysis ◽  
Vaccine Effectiveness ◽  
The Other ◽  
Influenza Vaccines ◽  
High Dose ◽  
Office Visits ◽  
Trivalent Influenza Vaccine ◽  
Respiratory Events

The influenza-related disease burden is highest among the elderly. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) compared to other egg-based influenza vaccines (high-dose trivalent (TIV-HD), quadrivalent (QIVe-SD), and standard-dose trivalent (TIVe-SD)) against influenza-related and cardio-respiratory events among subjects aged ≥65 years for the 2017–2018 influenza season. This retrospective cohort analysis used prescription claims, professional fee claims, and hospital charge master data. Influenza-related hospitalizations/ER visits and office visits and cardio-respiratory events were assessed post-vaccination. Inverse probability of treatment weighting (IPTW) and Poisson regression were used to evaluate the adjusted rVE of aTIV compared to other vaccines. In an economic analysis, annualized follow-up costs were compared between aTIV and TIV-HD. The study was composed of 234,313 aTIV, 1,269,855 TIV-HD, 212,287 QIVe-SD, and 106,491 TIVe-SD recipients. aTIV was more effective in reducing influenza-related office visits and other respiratory-related hospitalizations/ER visits compared to the other vaccines. For influenza-related hospitalizations/ER visits, aTIV was associated with a significantly higher rVE compared to QIVe-SD and TIVe-SD and was comparable to TIV-HD. aTIV was also associated with a significantly higher rVE compared to TIVe-SD against hospitalizations/ER visits related to pneumonia and asthma/COPD/bronchial events. aTIV and TIV-HD were associated with comparable annualized all-cause and influenza-related costs. Adjusted analyses demonstrated a significant benefit of aTIV against influenza- and respiratory-related events compared to the other egg-based vaccines.

scholarly journals 29. Impact of Enhanced Influenza Vaccines on Direct Healthcare Costs for the U.S. Elderly: A Comprehensive Real-World Evaluation of Adjuvanted Trivalent Influenza Vaccine Compared to Trivalent High-Dose Influenza Vaccine for the 2018–19 Influenza Season

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S38-S39
Author(s):  
Maarten Postma ◽  
Stephen I Pelton ◽  
Victoria Divino ◽  
Joaquin F Mould-Quevedo ◽  
Drishti Shah ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Healthcare Costs ◽  
Influenza Season ◽  
Elderly Subjects ◽  
High Dose ◽  
Office Visits ◽  
Research Support ◽  
Physician Office ◽  
Trivalent Influenza Vaccine ◽  
The U.S

Abstract Background Influenza generates a substantial economic burden ($3.2B in the U.S. annually) due to direct medical costs such as physician office visits or hospitalizations, especially among the elderly. Recent published literature for the 2018–19 influenza season has demonstrated similar clinical effectiveness between adjuvanted trivalent influenza vaccine (aTIV) and trivalent high dose influenza vaccine (TIV-HD). This research aimed to assess the annualized mean all-cause and influenza-related healthcare costs among subjects 65+ years vaccinated with aTIV or TIV-HD during the 2018–19 influenza season. Methods A retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index, comorbidities, indicators of frail health status, and pre-index hospitalization rates. Treatment selection bias was adjusted through 1:1 propensity score matching (PSM). Economic outcomes included annualized mean all-cause costs and influenza-related costs, which comprised influenza-related hospitalizations, emergency room (ER) visits, and physician office visits costs. Mean costs were compared using paired t-test. Adjusted analyses were conducted using generalized estimating equation (GEE) models, with two-part models for influenza-related costs. With the GEEs, adjustment for outliers (99th percentile) were addressed and predicted healthcare costs were obtained through bootstrapping (500 replications). Results During the 2018–19 influenza season, the PSM sample comprised 561,243 recipients of aTIV and 561,243 recipients of TIV-HD. Following GEE adjustment, predicted mean annualized all-cause and influenza-related costs per patient were statistically similar between aTIV and TIV-HD (US$9,676 vs. US$9,625 and US$23.75 vs. US$21.79, respectively). Both aTIV and TIV-HD were comparable in terms of predicted mean annualized costs for influenza-related hospitalizations (US$20.28 vs. US$18.13) and influenza-related office visits (US$1.29 vs. US$1.34). Conclusion In adjusted analyses, total all-cause and influenza-related healthcare costs were comparable among elderly subjects vaccinated with either aTIV or TIV-HD. Disclosures Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)

scholarly journals Comparing the Clinical and Economic Outcomes Associated with Adjuvanted versus High-Dose Trivalent Influenza Vaccine among Adults Aged ≥ 65 Years in the US during the 2019–20 Influenza Season—A Retrospective Cohort Analysis

Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1146
Author(s):  
Myron J. Levin ◽  
Victoria Divino ◽  
Drishti Shah ◽  
Mitch DeKoven ◽  
Joaquin Mould-Quevedo ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Retrospective Cohort ◽  
Linear Models ◽  
Influenza Season ◽  
Cohort Analysis ◽  
Economic Outcomes ◽  
High Dose ◽  
Hospital Data ◽  
Trivalent Influenza Vaccine ◽  
Retrospective Cohort Analysis

The burden of influenza is disproportionally higher among older adults. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent (aIIV3) compared to high-dose trivalent influenza vaccine (HD-IIV3e) against influenza and cardio-respiratory disease (CRD)-related hospitalizations/ER visits among adults ≥65 years during the 2019–2020 influenza season. Economic outcomes were also compared. A retrospective cohort analysis was conducted using prescription, professional fee claims, and hospital data. Inverse probability of treatment weighting (IPTW) was used to adjust for confounding. IPTW-adjusted Poisson regression was used to evaluate the adjusted rVE of aIIV3 versus HD-IIV3e. All-cause and influenza-related healthcare resource utilization (HCRU) and costs were examined post-IPTW. Recycled predictions from generalized linear models were used to estimate adjusted costs. Adjusted analysis showed that aIIV3 (n = 798,987) was similarly effective compared to HD-IIV3e (n = 1,655,979) in preventing influenza-related hospitalizations/ER visits (rVE 3.1%; 95% CI: −2.8%; 8.6%), hospitalizations due to any cause (−0.7%; 95% CI: −1.6%; 0.3%), and any CRD-related hospitalization/ER visit (0.9%; 95% CI: 0.01%; 1.7%). Adjusted HCRU and annualized costs were also statistically insignificant between the two cohorts. The adjusted clinical and economic outcomes evaluated in this study were comparable between aIIV3 and HD-IIV3e during the 2019–2020 influenza season.

scholarly journals LB15. Vaccine Effectiveness of Flucelvax Relative to Inactivated Influenza Vaccine During the 2017–18 Influenza Season in Northern California

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S764-S764 ◽  
Author(s):  
Nicola P Klein ◽  
Bruce Fireman ◽  
Kristin Goddard ◽  
Ousseny Zerbo ◽  
Jason Asher ◽  
...  
Keyword(s):  
Cell Culture ◽  
Influenza Vaccine ◽  
Influenza A ◽  
Cox Regression ◽  
Influenza Season ◽  
Cohort Analysis ◽  
Vaccine Effectiveness ◽  
Northern California ◽  
Research Support ◽  
Significant Difference

Abstract Background In June 2018, the CDC reported that influenza vaccine effectiveness (VE) against A(H3N2) influenza virus for the 2017–2018 season was ~24%. This lower than expected VE was hypothesized to be partially related to genetic changes arising in the vaccine virus during passage in eggs. Flucelvax™ (Seqirus) is a cell culture-based inactivated influenza vaccine (ccIIV) which is not manufactured in eggs. We investigated whether the VE of ccIIV against influenza A differed from that of egg-based IIV (ebIIV) during the 2017–2018 influenza season. Methods The study included all Kaiser Permanente Northern California members aged 4–64 years. We identified all individuals who were positive for influenza by polymerase chain reaction (PCR). This cohort analysis estimated the relative VE of ccIIV vs. ebIIV by comparing the ccIIV vaccinees vs. the ebIIV vaccinees with respect to the risk of PCR-confirmed influenza. We separately estimated the absolute VE of ccIIV and ebIIV by comparing each group of vaccinees with unvaccinated individuals. We used Cox regression with a calendar timeline, stratified by birth year, and adjusted for facility, race, years of membership, prior season influenza vaccine, co-morbidities, and number of inpatient admits in the prior year. We calculated VE as 1 − hazard ratio (HR). Results Of the 3,015,891 members aged 4–64 years, 1,017,314 were vaccinated. Of these, 932,874 (91.7%) received ebIIV and 84,440 (8.3%) received ccIIV. Most ebIIV (86.2%) was trivalent. Comparing ccIIV with ebIIV, the adjusted relative VE against influenza A was 6.8% (95% CI: 11.2, 21.9; P = 0.43). The adjusted absolute VE vs. unvaccinated of ccIIV was 30.2% (95% CI: 17.1, 41.3; P < 0.0001) and of ebIIV was 17.9% (95% CI: 12.1, 23.3; P < 0.0001). Conclusion Both cell-culture and egg-based IIV vaccines showed relatively low effectiveness during the 2017–2018 influenza season in which A(H3N2) predominated. The findings of this study show there was no significant difference in the effectiveness of cell-culture IIV compared with egg-based IIVs. Improvements in influenza vaccines will require ongoing monitoring of vaccine effectiveness. Disclosures N. P. Klein, GSK: Investigator, Research support. Sanofi Pasteur: Investigator, Research support. Merck: Investigator, Research support. Pfizer: Investigator, Research support. Protein Science: Investigator, Research support. MedImmune: Investigator, Research support. Dynavax: Investigator, Research support.

scholarly journals 150. Relative Effectiveness of High-Dose and Standard-Dose Influenza Vaccine Against Influenza-Related Hospitalization Among Older Adults—United States, 2015–2017

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S10-S10
Author(s):  
Joshua Doyle ◽  
Lauren Beacham ◽  
Elif Alyanak ◽  
Manjusha Gaglani ◽  
Emily T Martin ◽  
...  
Keyword(s):  
United States ◽  
Older Adults ◽  
Influenza Vaccine ◽  
Influenza A ◽  
Standard Dose ◽  
Relative Effectiveness ◽  
The United States ◽  
Vaccine Effectiveness ◽  
High Dose ◽  
Research Grant

Abstract Background Seasonal influenza causes substantial morbidity and mortality, and older adults are disproportionately affected. Newer vaccines have been developed for use in people 65 years and older, including a trivalent inactivated vaccine with a 4-fold higher dose of antigen (IIV-HD). In recent years, the use of IIV-HD has increased sufficiently to evaluate its effectiveness compared with standard-dose inactivated influenza vaccines (IIV-SD). Methods Hospitalized patients with acute respiratory illness were enrolled in an observational vaccine effectiveness study at 8 hospitals in 4 states participating in the United States Hospitalized Adult Influenza Vaccine Effectiveness Network during the 2015–2016 and 2016–2017 influenza seasons. Predominant influenza A virus subtypes were H1N1 and H3N2, respectively, during these seasons. All enrolled patients were tested for influenza virus with polymerase chain reaction. Receipt and type of influenza vaccine was determined from electronic records and chart review. Odds of laboratory-confirmed influenza were compared among vaccinated and unvaccinated patients. Relative odds of laboratory-confirmed influenza were determined for patients who received IIV-HD or IIV-SD, and adjusted for potential confounding variables via logistic regression. Results Among 1,744 enrolled patients aged ≥ 65 years, 1,105 (63%) were vaccinated; among those vaccinated, 621 (56%) received IIV-HD and 484 (44%) received IIV-SD. Overall, 315 (18%) tested positive for influenza, including 97 (6%) who received IIV-HD, 86 (5%) who received IIV-SD, and 132 (8%) who were unvaccinated. Controlling for age, race, sex, enrollment site, date of illness, index of comorbidity, and influenza season, the adjusted odds of influenza among patients vaccinated with IIV-HD vs. IIV-SD were 0.72 (P = 0.06, 95% CI: 0.52 to 1.01). Conclusion Comparison of high-dose vs. standard-dose vaccine effectiveness during 2 recent influenza seasons (1 H1N1 and 1 H3N2-predominant) suggested relative benefit (nonsignificant) of high-dose influenza vaccine in protecting against influenza-associated hospitalization among persons aged 65 years and older; additional years of data are needed to confirm this finding. Disclosures H. K. Talbot, sanofi pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.

scholarly journals 996. A Cluster-Randomized Trial of Adjuvanted Trivalent Influenza Vaccine vs. Standard Dose in US Nursing Homes

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S296-S296
Author(s):  
Stefan Gravenstein ◽  
H Edward Davidson ◽  
Kevin Mcconeghy ◽  
Lisa Han ◽  
David Canaday ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Proportional Hazards ◽  
Influenza Season ◽  
Standard Dose ◽  
Cox Proportional Hazards ◽  
Vaccine Response ◽  
Research Support ◽  
Data Set ◽  
Trivalent Influenza Vaccine ◽  
Research Grant

Abstract Background Pneumonia and influenza lead as vaccine-preventable infections among nursing home (NH) residents. Immunosenescence reduces vaccine response and protection from infections. More immunogenic vaccines, e.g., adjuvanted trivalent influenza vaccine [aTIV], can improve clinical outcomes. We evaluated all-cause hospitalization among long-stay NH residents offered aTIV vs. trivalent influenza vaccine (TIV). Methods We randomized 823 NHs within 75 miles of a Centers for Disease Control and Prevention influenza reporting city to offer one of the two egg-based influenza vaccines, aTIV or TIV, as their 2016–2017 influenza season standard of care. For the subset of long-stay NH residents (>100 days in facility as of October 1, 2016) aged ≥65 years, we determined how many were hospitalized from November 1, 2016 to June 1, 2017 on an intent-to-treat basis. We obtained all-cause hospitalization, patient-, and facility-level characteristics from Minimum Data Set and Certification and Survey Provider Enhanced Reporting data. Our primary outcome was time to first hospitalization, using Cox proportional hazards models. Results The analytic sample included 26,300 residents in 412 NHs randomized to offer aTIV and 26,474 in 410 NHs randomized to TIV. Mean age was 82.3 vs. 82.3 years, 69.3% vs. 68.6% were women, and 15.5% vs. 20.1% were African-American, for aTIV and TIV NHs, respectively. The number of residents vaccinated in the facility against influenza was 17,976 (68.3%) and 18,364 (69.4%), with an overall vaccination rate of 78.4% and 79% for aTIV and TIV NHs. Mean staff vaccination was 53.4% and 54.4% for aTIV and TIV NHs. There were 5,479 (20.8%) hospitalizations in the aTIV and 5,839 (22.1%) in TIV NHs, respectively [adjusted as prespecified, hazard ratio (HR) 0.94, 95% confidence interval (CI): 0.88, 0.99]. Post-hoc adjustment for the imbalance in race increased heterogeneity, HR 0.97, 95% CI: 0.91, 1.04. A total of 18.2% vs. 17.5% (HR 1.05, 95% CI: 0.99, 1.11) of residents in aTIV and TIV NHs died. Conclusion Compared with TIV, aTIV may reduce hospitalization risk of long-stay NH residents during a predominantly A/H3N2 influenza season, despite reported reduced effectiveness due to egg-based mutagenesis of egg-based vaccines. NCT: 02882100 Disclosures S. Gravenstein, Seqirus: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Speaker honorarium. H. E. Davidson, Seqirus: Grant Investigator and Investigator, Research grant and Research support. K. Mcconeghy, Seqirus: Investigator, Research support. L. Han, Seqirus: Investigator and Research Contractor, Research grant. D. Canaday, Seqirus: Grant Investigator, Research grant and Research support. E. Saade, Seqirus: Investigator, Research grant and Research support. R. R. Baier, Seqirus: Investigator, Research support. V. Mor, Seqirus: Investigator, Research grant and Research support.

scholarly journals Relative and Absolute Effectiveness of High-Dose and Standard-Dose Influenza Vaccine Against Influenza-Related Hospitalization Among Older Adults—United States, 2015–2017

2020 ◽  
Author(s):  
Joshua D Doyle ◽  
Lauren Beacham ◽  
Emily T Martin ◽  
H Keipp Talbot ◽  
Arnold Monto ◽  
...  
Keyword(s):  
United States ◽  
Older Adults ◽  
Influenza Vaccine ◽  
Standard Dose ◽  
Relative Effectiveness ◽  
Respiratory Illness ◽  
The United States ◽  
Vaccine Effectiveness ◽  
High Dose ◽  
Confounding Variables

Abstract Background Seasonal influenza causes substantial morbidity and mortality in older adults. High-dose inactivated influenza vaccine (HD-IIV), with increased antigen content compared to standard-dose influenza vaccines (SD-IIV), is licensed for use in people aged ≥65 years. We sought to evaluate the effectiveness of HD-IIV and SD-IIV for prevention of influenza-associated hospitalizations. Methods Hospitalized patients with acute respiratory illness were enrolled in an observational vaccine effectiveness study at 8 hospitals in the United States Hospitalized Adult Influenza Vaccine Effectiveness Network during the 2015–2016 and 2016–2017 influenza seasons. Enrolled patients were tested for influenza, and receipt of influenza vaccine by type was recorded. Effectiveness of SD-IIV and HD-IIV was estimated using a test-negative design (comparing odds of influenza among vaccinated and unvaccinated patients). Relative effectiveness of SD-IIV and HD-IIV was estimated using logistic regression. Results Among 1487 enrolled patients aged ≥65 years, 1107 (74%) were vaccinated; 622 (56%) received HD-IIV, and 485 (44%) received SD-IIV. Overall, 277 (19%) tested positive for influenza, including 98 (16%) who received HD-IIV, 87 (18%) who received SD-IIV, and 92 (24%) who were unvaccinated. After adjusting for confounding variables, effectiveness of SD-IIV was 6% (95% confidence interval [CI] −42%, 38%) and that of HD-IIV was 32% (95% CI −3%, 54%), for a relative effectiveness of HD-IIV versus SD-IIV of 27% (95% CI −1%, 48%). Conclusions During 2 US influenza seasons, vaccine effectiveness was low to moderate for prevention of influenza hospitalization among adults aged ≥65 years. High-dose vaccine offered greater effectiveness. None of these findings were statistically significant.

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