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1.
Stephanie Pepin Sandrine I. Samson Fabian P. Alvarez Martin Dupuy Viviane Gresset-Bourgeois Iris De Bruijn 《Vaccine》2019,37(13):1885-1888
Background
A multi-season phase III trial conducted in the Northern and Southern Hemispheres demonstrated the efficacy of a quadrivalent split-virion inactivated influenza vaccine (IIV4) in children 6–35?months of age.Methods
Data collected during the phase III trial were analysed to examine the vaccine efficacy (VE) of IIV4 in preventing laboratory-confirmed influenza in age subgroups and to determine the relative risk for IIV4 vs. placebo for severe outcomes, healthcare use, and parental absenteeism from work associated with laboratory-confirmed influenza.Results
VE (95% confidence interval [CI]) to prevent laboratory-confirmed influenza due to any A or B strain was 54.76% (40.24–66.03%) for participants aged 6–23?months and 46.91% (23.57–63.53%) for participants aged 24–35?months. VE (95% CI) to prevent laboratory-confirmed influenza due to vaccine-similar strains was 74.51% (53.55–86.91%) for participants aged 6–23?months and 59.78% (19.11–81.25%) for participants aged 24–35?months. Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96–89.34%) for acute otitis media, 21.76% (6.46–58.51%) for acute lower respiratory infection, 40.80% (29.62–55.59%) for healthcare medical visits, 29.71% (11.66–67.23%) for parent absenteeism from work, and 39.20% (26.89–56.24%) for antibiotic use.Conclusion
In children aged 6–35?months, vaccination with IIV4 reduces severe outcomes of influenza as well as the associated burden for their parents and the healthcare system. In addition, vaccination with IIV4 is effective at preventing against influenza in children aged 6–23 and 24–35?months.Trial registration: EudraCT no. 2013-001231-51. 相似文献2.
Stephanie Pepin Martin Dupuy Charissa Fay Corazon Borja-Tabora May Montellano Lulu Bravo Jaime Santos Jo-Anne de Castro Doris Maribel Rivera-Medina Clare Cutland Miguel Ariza Javier Diez-Domingo Celia Diaz Gonzalez Federico Martinón-Torres Efimia Papadopoulou-Alataki Maria Theodoriadou Marie Pierre Kazek-Duret Sanjay Gurunathan Iris De Bruijn 《Vaccine》2019,37(13):1876-1884
Background
A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra?, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged?≥?3?years. This study examined the efficacy and safety of IIV4 in children aged 6–35?months.Methods
This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6–35?months not previously vaccinated against influenza were randomised to receive two full doses 28?days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.Results
The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36–61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07–81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.Conclusions
IIV4 was safe and effective for protecting children aged 6–35?months against influenza illness caused by vaccine-similar or any circulating strains.Clinical trial registration
EudraCT no. 2013-001231-51. 相似文献3.
Penina Haber Pedro L. Moro Carmen Ng Graça M. Dores Paige Lewis Maria Cano 《Vaccine》2019,37(11):1516-1520
Background
Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the United States (U.S.) in 2015 for adults aged ≥65?years and has been in use since the 2016–17 influenza season.Methods
We analyzed U.S. reports for aIIV3 submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. Medical records were reviewed for serious reports. Among individuals ≥65?years of age, the relative frequency of the most commonly reported adverse events (AEs) after aIIV3 were compared with non-adjuvanted inactivated influenza vaccines given to adults aged ≥65?years, high-dose trivalent influenza vaccine (IIV3-HD) and trivalent or quadrivalent vaccines (IIV3/IIV4). Data mining analyses were undertaken to identify whether AEs for aIIV3 occurred disproportionately more than expected compared to all influenza vaccines.Results
VAERS received 630 reports after aIIV3, of which 521 (83%) were in adults aged ≥65?years; 79 (13%) in persons <65?years and in 30 (5%) reports age was missing; 19 (3%) reports were serious, including two deaths (0.4%) related to myocardial infarction and Sjogren’s syndrome. The most common AEs reported in adults aged ≥65?years were injection site pain (21%) and erythema (18%), with similar proportions reported for IIV3-HD (17% and 19%, respectively) and for IIV3/IIV4 (15%, each). Except for reports related to vaccination of inappropriate age (n?=?79) and syringe malfunction (n?=?6), data mining did not identify other disproportionately reported AEs.Conclusions
Although our review of aIIV3 in VAERS did not identify any unexpected health conditions of concern, we observed more than twice the expected number of reports with administration of the vaccine to persons outside of the age range for which the vaccine is approved in the U.S. Health care providers should be educated on the age groups for whom aIIV3 is recommended. 相似文献4.
Annette K. Regan James E. Fielding Monique B. Chilver Kylie S. Carville Cara A. Minney-Smith Kristina A. Grant Chloe Thomson Trish Hahesy Yi-Mo Deng Nigel Stocks Sheena G. Sullivan 《Vaccine》2019,37(19):2634-2641
Background
We estimated the effectiveness of seasonal inactivated influenza vaccine and the potential influence of timing of immunization on vaccine effectiveness (VE) using data from the 2016 southern hemisphere influenza season.Methods
Data were pooled from three routine syndromic sentinel surveillance systems in general practices in Australia. Each system routinely collected specimens for influenza testing from patients presenting with influenza-like illness. Next generation sequencing was used to characterize viruses. Using a test-negative design, VE was estimated based on the odds of vaccination among influenza-positive cases as compared to influenza-negative controls. Subgroup analyses were used to estimate VE by type, subtype and lineage, as well as age group and time between vaccination and symptom onset.Results
A total of 1085 patients tested for influenza in 2016 were included in the analysis, of whom 447 (41%) tested positive for influenza. The majority of detections were influenza A/H3N2 (74%). One-third (31%) of patients received the 2016 southern hemisphere formulation influenza vaccine. Overall, VE was estimated at 40% (95% CI: 18–56%). VE estimates were highest for patients immunized within two months prior to symptom onset (VE: 60%; 95% CI: 26–78%) and lowest for patients immunized >4?months prior to symptom onset (VE: 19%; 95% CI: ?73–62%).Discussion
Overall, the 2016 influenza vaccine showed good protection against laboratory-confirmed infection among general practice patients. Results by duration of vaccination suggest a significant decline in effectiveness during the 2016 influenza season, indicating immunization close to influenza season offered optimal protection. 相似文献5.
6.
Background
To support timely, annual estimation of influenza vaccine effectiveness (VE), we explored the use of automated data extraction from general practice records to estimate VE over four consecutive southern hemisphere influenza seasons.Methods
A software tool installed at 130 practices in Western Australia identified all outpatients tested for influenza by polymerase-chain-reaction (PCR) during annual influenza seasons occurring 2012–2015. Laboratory test results were collated with any existing record of influenza vaccine administered in the same year; limited patient demographic and clinical information was also collected. A case test-negative control analysis compared the odds of seasonal influenza vaccination between patients positive or negative for influenza by PCR with VE?=?1???the odds ratio.Results
A total of 7270 influenza PCR test results were identified of which 1907 (26.2%) were positive; 9.4% of patients with a positive result had received contemporaneous influenza vaccination ≥14?days prior to specimen collection, compared to 17.9% of those with a negative result. Overall VE was 52% (95% CI, 43–60%); annual VE estimates ranged from 46% (95% CI, 22–63%) in 2012 to 60% (95% CI, 41–73%) in 2014.Conclusion
Electronic records routinely maintained by general practice provide a promising opportunity for estimating annual influenza VE in a timely and resource-efficient manner. 相似文献7.
《Vaccine》2018,36(18):2456-2461
BackgroundThe effectiveness of influenza vaccine among nursery school children has not been systematically studied. We conducted a cohort study of children from 13 nursery schools in Suzhou, China, to estimate the effectiveness of influenza vaccine against laboratory-confirmed influenza during 2016–17.MethodsChildren aged 36–72 months were chosen from 13 nursery schools from 3 District in Suzhou. The surveillance started 2 weeks after vaccination during October 2016–February 2017. Class teachers reported the names of students with ILI (influenza-like illness) to study clinicians on each school day. Further, local physicians collected the student’s nasopharyngeal swab or throat swab, either at a study clinic or at the child’s home. The swabs were sent to the National Influenza Network Laboratory in Suzhou Center for Disease Control and Prevention for influenza testing by RT-PCR.ResultA total of 4614 children were enrolled, of which 15 children (vaccinated: 2; unvaccinated: 13) were lost to follow-up. Of the remaining 4599 children, 558 swabs were collected. Among these swabs, 70 samples tested positive for influenza virus; 17 in the vaccinated group (B Victoria: 2; H3N2: 15) and 53 in the unvaccinated group (B Victoria: 14; A(H1N1)pdm09: 1; H3N2: 38). The overall influenza vaccine effectiveness (VE) during the influenza season of 2016–2017 was 20.6%. The incidence of developing ILI symptoms and healthcare seeking behavior through clinical visits was significantly lower in vaccinated children than in the unvaccinated group.ConclusionInfluenza vaccine protection in vaccinated and unvaccinated children showed no statistical difference and the VE percentage varied for different virus subtypes. However, the incidence rate of developing ILI and healthcare seeking behavior was significant lower in the vaccinated group than in the unvaccinated children. Larger studies are required to estimate the VE according to the influenza type, subtype, and lineage during influenza seasons in China in the future. 相似文献
8.
Joshua G. Petrie Emily T. Martin Rachel Truscon Emileigh Johnson Caroline K. Cheng E.J. McSpadden Ryan E. Malosh Adam S. Lauring Lois E. Lamerato Maryna C. Eichelberger Jill M. Ferdinands Arnold S. Monto 《Vaccine》2019,37(10):1284-1292
Background
Influenza vaccines are important for prevention of influenza-associated hospitalization. However, the effectiveness of influenza vaccines can vary by year and influenza type and subtype and mechanisms underlying this variation are incompletely understood. Assessments of serologic correlates of protection can support interpretation of influenza vaccine effectiveness in hospitalized populations.Methods
We enrolled adults hospitalized for treatment of acute respiratory illnesses during the 2014–2015 and 2015–2016 influenza seasons whose symptoms began <10?days prior to enrollment. Influenza infection status was determined by RT-PCR. Influenza vaccination status was defined by self-report and medical record/registry documentation. Serum specimens collected at hospital admission were tested in hemagglutination-inhibition (HAI) and neuraminidase-inhibition (NAI) assays. We evaluated how well antibody measured in these specimens represented pre-infection immune status, and measured associations between antibody and influenza vaccination and infection.Results
Serum specimens were retrieved for 315 participants enrolled during the 2014–2015 season and 339 participants during the 2015–2016 season. Specimens were collected within 3?days of illness onset from 65% of participants. Geometric mean titers (GMTs) did not vary by the number of days from illness onset to specimen collection among influenza positive participants suggesting that measured antibody was representative of pre-infection immune status rather than a de novo response to infection. In both seasons, vaccinated participants had higher HAI and NAI GMTs than unvaccinated. HAI titers against the 2014–2015 A(H3N2) vaccine strain did not correlate with protection from infection with antigenically-drifted A(H3N2) viruses that circulated that season. In contrast, higher HAI titers against the A(H1N1)pdm09 vaccine strain were associated with reduced odds of A(H1N1)pdm09 infection in 2015–2016.Conclusions
Serum collected shortly after illness onset at hospital admission can be used to assess correlates of protection against influenza infection. Broader implementation of similar studies would provide an opportunity to understand the successes and shortcomings of current influenza vaccines. 相似文献9.
《Vaccine》2015,33(25):2917-2921
In 2012–2013, we examined 1729 laboratory-confirmed A(H1N1)pdm09 influenza cases matched 1:1 with healthy controls and estimated influenza vaccine effectiveness (VE) for trivalent inactivated influenza vaccine (IIV3) to be 67% (95% confidence interval = 58–74%) for ages 8 months to 6 years old. Among children aged 8–35 months old, VE for fully vaccinated children (73%, 60–81%) was significantly higher than VE for partially vaccinated children (55%, 33–70%). Significant cross-season protection from prior IIV3 was noted, including VE of 31% (8–48%) from IIV3 received in 2010–2011 against influenza illness in 2012––2013 without subsequent boosting doses. 相似文献
10.
Jennifer Milucky Maria de Gloria Carvalho Nadine Rouphael Nancy M. Bennett H.Keipp Talbot Lee H. Harrison Monica M. Farley Jeremy Walston Fabiana Pimenta Fernanda C. Lessa 《Vaccine》2019,37(8):1094-1100
Background
Vaccination of children with 13-valent pneumococcal conjugate vaccine (PCV13) led to declines in vaccine-type pneumococcal nasopharyngeal carriage among adults through indirect effects. In August 2014, PCV13 immunization of all U.S. adults ≥65?years of age was recommended. This study sought to define prevalence and serotype distribution of pneumococcal carriage among adults ≥65?years of age and to describe risk factors for colonization soon after introduction of PCV13 in adults.Methods
A cross-sectional survey of non-institutionalized U.S. adults ≥65?years of age was conducted in four states in 2015–2016. Demographic information, risk factors for disease, PCV13 vaccination history, and nasopharyngeal (NP) and oropharyngeal (OP) swabs were collected. NP and OP swabs were processed separately and pneumococcal isolates were serotyped by Quellung reaction. Antimicrobial susceptibility of pneumococcal isolates was performed. NP swabs also underwent real-time PCR for pneumococcal detection and serotyping.Results
Of 2989 participants, 45.3% (1354/2989) had been vaccinated with PCV13. Fifty-five (1.8%) carried pneumococcus (45 identified by culture and 10 by real-time PCR only) and PCV13 serotypes were found in eight (0.3%) participants. Almost half (22/45) of pneumococcal isolates were not susceptible to at least one of the antibiotics tested. Vaccine-type carriage among vaccinated and unvaccinated individuals was similar (0.2% vs. 0.1%, respectively). Respiratory symptoms were associated with higher odds of pneumococcal colonization (adjusted OR: 2.1; 95% CI?=?1.1–3.8).Conclusions
Pneumococcal carriage among non-institutionalized adults ≥65?years of age was very low. Less than 0.5% of both vaccinated and unvaccinated individuals in our study carried vaccine-type serotypes. Over a decade of PCV vaccination of children likely led to indirect effects in adults. However, given the low vaccine-type carriage rates we observed in an already high PCV13 adult coverage setting, it is difficult to attribute our findings to the direct versus indirect effects of PCV13 on adult carriage. 相似文献11.
Cristina Andrés Paula Peremiquel-Trillas Laura Gimferrer Maria Piñana Maria Gema Codina José Ángel Rodrigo-Pendás Magda Campins-Martí María Carmen Martín Francisco Fuentes Susana Rubio Tomàs Pumarola Andrés Antón 《Vaccine》2019,37(18):2470-2476
Background
Influenza viruses (FLUV) are continuously evolving, which explain the occurrence of seasonal influenza epidemics and the need to review the vaccine strain composition annually. The aim is to describe the genetic diversity and clinical outcomes of FLUV detected at a tertiary university hospital in Barcelona (Spain) during the 2012–2016 seasons.Methods
The detection of FLUV from patients attended at the Emergency Department or admitted to the hospital was performed by either immunofluorescence or PCR-based assays. A specific real-time one-step multiplex RT-PCR was performed for influenza A (FLUAV) subtyping. The complete coding haemagglutinin domain 1 (HA1) and neuraminidase (NA) (2015–2016) protein sequences from a representative sampling were molecular characterised.Results
A total 1774 (66.1%) FLUAV and 910 (33.9%) influenza B (FLUBV) cases were laboratory-confirmed. The hospitalisation rate was different between seasons, being the highest (81.4%) during the 2014–2015 season. FLUV were genetically close to vaccine strains except to the 2014–2015, in which most characterised A(H3N2) viruses belonged to a genetic group different from the vaccine strain. During the 2015–2016 season, B/Victoria-like viruses were the most predominant, but this component was not included in the trivalent vaccine used. Mutations D222G or D222N in HA1-domain were found in 3 A(H1N1)pdm09 strains from ICU-admitted cases. Three A(H1N1)pdm09 strains carried the NA H275Y (2) and S247N (1) mutations, respectively related to resistance or decreased susceptibility to oseltamivir.Conclusions
The circulation of drifted A(H3N2) strains during the 2014–2015 season was related to the high hospitalisation rate due to the mismatch with the vaccine strains. The predominance of a FLUBV lineage not included in the trivalent influenza vaccine during the 2015–2016 season highlights the need to use a tetravalent influenza vaccine. Virological surveillance of viral variants carrying protein changes that alter tropism and susceptibility to antivirals features should be strengthened in hospital settings. 相似文献12.
Introduction
Influenza causes significant morbidity among young children, and vaccination remains the best strategy to prevent disease. Understanding factors influencing early influenza vaccination uptake are important to identify strategies to increase vaccination rates.Objective
To assess maternal and neonatal factors associated with influenza vaccination among first-born children within the first two years of life.Methods
We conducted a retrospective population-based cohort study linking Colorado Birth Registry data and state immunization data of all live births between 2008 and 2016. The cohort was limited to singleton, first births. Multivariable logistic regression was used to assess associations between maternal and neonatal factors and influenza vaccination.Results
Among 126,763 births meeting criteria for inclusion, 50.2% were vaccinated against influenza by two years of age. Mothers of unvaccinated children were older (27 vs 26?years, p?<?0.0001), married (67.8% vs 66.8%, p?<?0.0001), with a college education (38.8% vs 37.2%, p?<?0.0001). Influenza vaccination rates declined over time by birth year (30.5% in 2009 vs 6.8% in 2013, p?<?0.0001). Children admitted to the NICU receiving oxygen with 72?h of birth were 20% less likely to be vaccinated (RR?=?0.8, 95% CI: 0.67–0.96) after adjusting for maternal age, race/ethnicity, education and preterm birth. Conversely, premature births were associated with an increase in influenza vaccination by age two years (RR?=?1.1, 95%CI: 1.05, 1.15).Conclusions
Among a large population-based cohort of mother-infant pairs in Colorado using birth and immunization registry data, there were statistically significant differences in maternal factors between unvaccinated and vaccinated children with influenza in the first 2?years of life, but the differences were too small to be clinically significant. Children admitted to the NICU were 20% less likely to be vaccinated, highlighting the need to target influenza vaccination in this population once eligible. Ongoing studies are needed to explore factors associated with early influenza vaccination. 相似文献13.
《Vaccine》2017,35(33):4088-4093
BackgroundTrivalent inactivated and live attenuated influenza vaccines (IIV3 and LAIV3) have been reformulated with an extra B strain (IIV4 and LAIV4). They were licensed based on immunogenicity and their effectiveness (VE) still must be empirically tested.MethodsChildren 1–17 years tested for influenza during 2013–16 were included and their immunization status verified. They were considered vaccinated if received ≥1 dose of an influenza vaccine ≥10 days before evaluated for a respiratory episode. Age-groups were classified as 1–4 years or 5–17 years. VE was estimated by comparing vaccination status of influenza-positive versus influenza-negative cases.Results6779 children were enrolled in the three seasons. Overall, 27.2% received an influenza vaccine (87.1% IIV3 or IIV4 and 12.9% LAIV4), and 15.6% tested positive for influenza (77.9% A). IIV3 was predominantly used in 2013–14 and IIV4 in 2014–15 and 2015–16. IIV3 and IIV4 had comparable VE over the three seasons (60%, 57% and 53%) and performed similarly against influenza A and B and both age-groups. LAIV4 performed poorly for influenza A (15%, 37% and 48%) but better for influenza B (100%, 56% and 100%), especially among children 5–17 years of age with VE = 100% (95%CI: 55, 100).ConclusionsInfluenza vaccination showed modest but consistent effectiveness over the years. The switch from IIV3 to IIV4 did not affect VE. LAIV4 did not perform as well as IIVs, yet it improved over the years and was particularly good protecting older children against influenza B. These results emphasize the regional nature of influenza and the need for local surveillance. 相似文献
14.
Peng Yang Mark G. Thompson Chunna Ma Weixian Shi Shuangsheng Wu Daitao Zhang Quanyi Wang 《Vaccine》2014
Background
Influenza vaccine coverage remains low in China, and there is limited information on the preventive value of local vaccination programs.Methods
As part of influenza virological surveillance in Beijing, China during the 2012–2013 influenza season, we assessed the vaccine effectiveness (VE) of one or more doses of trivalent inactivated influenza vaccine (IIV3) in preventing medically-attended influenza-like-illness (ILI) associated with laboratory-confirmed influenza virus infection using a test-negative case–control design. Influenza vaccination was determined based on self-report by adult patients or the parents of child patients.Results
Of 1998 patients with ILI, 695 (35%) tested positive for influenza viruses, including 292 (42%) A(H3N2), 398 (57%) A(H1N1)pdm09, and 5 (1%) not (sub)typed influenza viruses. The rate of influenza vaccination among all patients was 4% (71/1998). Among influenza positive patients, 2% (57/1303) were vaccinated compared to 4% (14/695) among influenza negative patients, resulting in VE for one or more doses of vaccine (adjusted for age, sex, week, and days since illness onset) against all circulating influenza viruses of 52% (95% CI = 12–74%). A significant adjusted VE for one or more doses of vaccine for all ages against A(H1N1)pdm09 of 59% (95% CI, 8–82%) was observed; however, the VE against A(H3N2) was 43% (95% CI, −30% to 75%). The point estimate of VE was 59% (95% CI, 19–79%) for those aged <60 years, but a negative VE point estimate without statistical significance was observed among those aged ≥60 years.Conclusions
IIV3 conferred moderate protection against medically-attended influenza in Beijing, China during the 2012–2013 season, especially against the A(H1N1)pdm09 strain and among those aged <60 years old. 相似文献15.
16.
Jacqueline M. Hirth Erika L. Fuchs Mihyun Chang Maria E. Fernandez Abbey B. Berenson 《Vaccine》2019,37(4):595-601
Background
Human papillomavirus (HPV) vaccination is expected to reduce HPV-related disease and cancer in the US. However, many parents are hesitant to obtain the vaccine for their children. The purpose of this study is to examine how the reasons for refusing the HPV vaccine vary across regions of the US, across time, and by race/ethnicity.Methods
This study used data on 13–17?year old adolescents collected by the National Immunization Survey – Teen (NIS-Teen) annually between 2008 and 2016. We evaluated the frequencies of parents who did not intend to vaccinate their children in the next year among unvaccinated children. Among these non-intenders, we evaluated how reasons for HPV vaccine hesitancy changed across time, by region of the US, and race/ethnicity.Results
The proportion of non-intenders among unvaccinated decreased from 72% in 2010 to 58% in 2016. The most frequent reason for vaccine hesitancy was that parents felt HPV vaccination was not necessary (22.4%), followed by lack of provider recommendation (16.2%), and lack of knowledge (15.6%). Lack of provider recommendation increased in frequency as a reason for HPV vaccine hesitancy until 2012, then decreased in frequency through 2016. Cost was one reason that was elevated in all regions compared to the Northeast. Black non-intenders were less likely to report safety, costs, or their children’s fear as reasons for not intending to vaccinate their children compared to white non-intenders. Hispanic non-intenders were more likely to report lack of knowledge and that the vaccine is not a school requirement as reasons not to vaccinate their children compared to white non-intenders.Conclusions
National advocacy for improving provider recommendation for HPV vaccination likely contributed to a sharp decline in HPV vaccine hesitancy due to lack of provider recommendation. Results indicate the need for multifaceted interventions to increase HPV vaccination. 相似文献17.
Background
There were increased reports of fevers and febrile reactions in young children (particularly children aged <5?years) receiving the Seqirus/CSL Southern Hemisphere 2010 trivalent inactivated influenza vaccine (IIV3). Modifying the vaccine manufacturing process by increasing the minimum concentration of splitting agent (sodium taurodeoxycholate [TDOC]) from 0.5% w/v to 1.5% w/v for all strains resolved this issue. The current analysis compared fever rates in three pediatric studies of Seqirus IIV3 (S-IIV3) or quadrivalent inactivated influenza vaccine (S-IIV4), prepared using the modified manufacturing process, with fever rates in three pediatric studies of historical (pre-2010) IIV3 formulations. The historical IIV3 formulations, S-IIV3, and S-IIV4 had 0/3, 2/3, and 4/4 vaccine strains split at 1.5% TDOC, respectively.Methods
For each study, fever rates (any grade and severe) were determined for the following age subgroups (as applicable), using the fever intensity grading system used in the S-IIV3/S-IIV4 studies: 6?months to <3?years; 3 to <5?years; 5 to <9?years; and 9 to <18?years.Results
For each age subgroup, the any grade and severe fever rates were lower in the S-IIV3/S-IIV4 studies than in the historical IIV3 formulation studies, with the greatest differences in fever rates observed in the youngest age groups. In the 6?months to <3?years group, the any grade fever rate was 7.0% (severe fever: 2.5%) in one S-IIV4 study compared with 38.7% to 40.0% (severe fever: 9.6% to 17.8%) in the historical IIV3 formulation studies. In the 3 to <5?years subgroup, the any grade fever rate was 4.9% (severe fever: 1.2%) in one S-IIV4 study compared with 34.1% to 36.0% (severe fever: 6.3% to 16.5%) in the historical IIV3 formulation studies.Conclusion
This analysis provides clinical evidence that the modified manufacturing process improved the fever profile across all pediatric age groups, in particular, in children aged <5?years. 相似文献18.
Victoria A. Statler Frank R. Albano Jolanta Airey Daphne C. Sawlwin Alison Graves Jones Vince Matassa Esther Heijnen Jonathan Edelman Gary S. Marshall 《Vaccine》2019,37(2):343-351
Background
In the Southern Hemisphere 2010 influenza season, Seqirus’ split-virion, trivalent inactivated influenza vaccine was associated with increased reports of fevers and febrile reactions in young children. A staged clinical development program of a quadrivalent vaccine (Seqirus IIV4 [S-IIV4]; Afluria® Quadrivalent/Afluria Quad?/Afluria Tetra?), wherein each vaccine strain is split using a higher detergent concentration to reduce lipid content (considered the cause of the increased fevers and febrile reactions), is now complete.Methods
Children aged 6–59?months were randomized 3:1 and stratified by age (6–35?months/36–59?months) to receive S-IIV4 (n?=?1684) or a United States (US)-licensed comparator IIV4 (C-IIV4; Fluzone® Quadrivalent; n?=?563) during the Northern Hemisphere 2016–2017 influenza season. The primary objective was to demonstrate noninferior immunogenicity of S-IIV4 versus C-IIV4. Immunogenicity was assessed by hemagglutination inhibition (baseline, 28?days postvaccination). Solicited, unsolicited, and serious adverse events were assessed for 7, 28, and 180?days postvaccination, respectively.Results
S-IIV4 met the immunogenicity criteria for noninferiority. Adjusted geometric mean titer ratios (C-IIV4/S-IIV4) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 0.79 (95% CI: 0.72, 0.88), 1.27 (1.15, 1.42), 1.12 (1.01, 1.24), and 0.97 (0.86, 1.09), respectively. Corresponding values for differences in seroconversion rates (C-IIV4 minus S-IIV4) were ?10.3 (?15.4, ?5.1), 2.6 (?2.5, 7.8), 3.1 (?2.1, 8.2), and 0.9 (?4.2, 6.1). Solicited, unsolicited, and serious adverse events were similar between vaccines in both age cohorts, apart from fever. Fever rates were lower with S-IIV4 (5.8%) than C-IIV4 (8.4%), with no febrile convulsions reported with either vaccine during the 7?days postvaccination.Conclusion
S-IIV4, manufactured with a higher detergent concentration, demonstrated noninferior immunogenicity to the US-licensed C-IIV4, with similar postvaccination safety and tolerability, in children aged 6–59?months. This completes the program demonstrating the immunogenicity and safety of S-IIV4 in participants aged 6?months and older.19.
Natasha S. Crowcroft Kevin L. Schwartz Cynthia Chen Caitlin Johnson Ye Li Alex Marchand-Austin Shelly Bolotin Frances B. Jamieson Steven J. Drews Margaret L. Russell Lawrence W. Svenson Kimberley Simmonds Salaheddin M Mahmud Jeffrey C. Kwong 《Vaccine》2019,37(19):2617-2623
Background
Resurgences of pertussis have occurred in several high-income countries, often linked to waning of immunity from acellular pertussis vaccines. The degree of waning observed has varied by study design and setting. In Ontario, pertussis has not shown a substantial resurgence in the past decade. The routine immunization schedule comprises three priming doses in infancy, toddler and pre-school doses, and an adolescent dose at 14–16?years of age.Methods
We estimated pertussis vaccine effectiveness (VE) through a case-control study of 1335 cases statutorily reported to public health in Ontario and occurring between January 1, 2009 and March 31, 2015, compared with 5340 randomly selected population controls, frequency-matched by age, primary-care provider and year of diagnosis. Pertussis cases met provincial confirmed or probable case definitions. We used multivariable logistic regression to estimate crude and adjusted odds ratios (aOR).Results
VE against pertussis was sustained between 92% (95% confidence interval (95%CI) 88–95%) in 2–3?year olds and 90% (95%CI: 80–95%) in 8–9?year olds, but fell rapidly to 49% (95%CI: 2–73%) in children 12–13?years of age. VE following the teenage booster given at 14–16?years in Ontario reached 76% (95%CI: 52–88%) in 14–16?year olds and 78% (95%CI: ?31 to 96%) in those 16–22?years old. For children who were up-to-date with the immunization schedule, VE declined from 87% (95%CI: 84–90%) during the first year to 74% (95%CI: 63–82%) after 8 or more years following their last dose of immunization.Conclusions
VE is high during the first decade of life but then falls rapidly. Protection is not fully restored by the teenage booster. Our findings are consistent with the localized outbreaks we observe in high school children and underline the importance of additional policies to protect infants. 相似文献20.
Fangjun Zhou Jing Xu Carla L. Black Helen Ding Bo-Hyun Cho Peng-Jun Lu Megan C. Lindley 《Vaccine》2019,37(14):1972-1977