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Literature Alerts

This section informs healthcare professionals of the latest medical information via daily news articles on respiratory disorders and other related areas.

Recent Headlines

  • A systematic review of compliance with palivizumab administration for RSV immunoprophylaxis.

    J Manag Care Pharm. 2010 Jan-Feb; 16(1): 46-58
    Frogel MP, Stewart DL, Hoopes M, Fernandes AW, Mahadevia PJ

    BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children, accounting for approximately 75,000-125,000 hospitalizations per year. It is estimated that in 2000, RSV infection accounted for 1.7 million office visits, 402,000 emergency room visits, and 236,000 hospital outpatient visits per year for children younger than 5 years of age. Palivizumab, a humanized monoclonal antibody directed against RSV, is the only immunoprophylaxis therapy approved by the FDA for prevention of serious lower respiratory tract disease caused by RSV in infants (up to 2 years of age) who meet 1 or more of the following criteria for high risk: (a) gestational age up to 35 weeks;(b) diagnosis of chronic lung disease (CLD, formerly bronchopulmonary dysplasia [BPD]); or (c) diagnosis of cyanotic or complex congenital heart disease. The RSV season typically occurs between November and March but may vary by region. During the period of our review, depending on local duration of the RSV season, infants usually required 5 monthly (every 28-30 days) intramuscular injections of palivizumab. Infants born in the middle of the season received their palivizumab doses from the time of birth to the end of the season and, therefore, may have required less than 5 doses.It is unclear if compliance with monthly doses is a problem and whether noncompliance increases the risk of RSV hospitalizations in routine clinical practice. OBJECTIVES: To (a) identify and describe compliance rates and the factors that influence parental compliance with immunoprophylaxis regimens, (b)review intervention programs and describe those that have been associated with increased compliance, and (c) summarize the association of compliance with RSV hospitalization rates. METHODS: An electronic literature search was conducted using journal databases, including Ovid, Current Contents, Embase, Medline In-Process & Other Non-Indexed Citations; Ovid Medline, PubMed, and Web of Science;and an abstract database, Medical Intelligence Solution, for citations through April 2008. Specific search terms used were palivizumab with patient compliance, patient adherence, or patient persistence. RESULTS: Twenty-five articles and abstracts met the inclusion criteria. Available studies were mostly retrospective or observational prospective.Compliance, defined in various ways across the studies, varied between 25% and 100%, and 12 studies identified some of the factors related to noncompliance. Compliance generally was lower among Medicaid patients,African American patients, and other minorities. Ten studies (3 manuscripts and 7 abstracts) investigated the association of administration of prophylaxis through monthly home visits by a health professional with parental compliance with therapy. Most of the home-based programs were associated with higher compliance rates compared with clinic or office programs.Rates as high as 94% and 64% were achieved when Medicaid infants and infants of minority descent, respectively, received their doses through a home health program. When these infants received their doses at a clinic or office, depending on the definition of compliance, rates were 61%-100% for Medicaid infants and 44% for infants of minority descent. Reminder telephone calls to parents or caregivers, comprehensive multidisciplinary programs that included extensive counseling of parents, calendars with sticker reminders, and education in the language native to parents also were associated with increased compliance, although statistical significance was reported in only 1 study. Several studies recommended educating parents on the benefits of RSV prophylaxis, alleviating transportation and language difficulties, recognizing cultural differences and biases, and clarifying misperception of RSV illness severity. Home health programs had lower rates of RSV hospitalizations than office-based programs in 3 analyses conducted in 2 studies. In 4 other abstracts, the rates of RSV hospitalization for home health programs and office-based administration did not significantly differ. In a large, 4-season, prospective outcome study, compliant infants had lower RSV hospitalization rates than those who were not compliant under one definition of compliance (doses within 35-day intervals). RSV hospitalization rates were not significantly different using another definition of compliance (receipt of anticipated doses, expected vs. observed rates).In a large survey of 10,390 infants identified from pharmacy dispensing records, RSV hospitalization rates were 1.4% in the compliant group versus 3.1% in the noncompliant group (OR = 2.2, 95% CI = 1.4-3.5, P < 0.001).Adjustment for confounding was not reported in these studies. CONCLUSION: Medicaid and minority infants were less likely to receive scheduled palivizumab doses. Home-based programs for the administration of palivizumab have been investigated more than other interventions and are associated with improved compliance compared with office-based administration. Compliance with dosing, in general, was associated with lower RSV hospitalization rates. However, these strategies should be further investigated using well-designed studies.

  • Respiratory viral infections in infants: causes, clinical symptoms, virology, and immunology.

    Clin Microbiol Rev. 2010 Jan; 23(1): 74-98
    Tregoning JS, Schwarze J

    In global terms, respiratory viral infection is a major cause of morbidity and mortality. Infancy, in particular, is a time of increased disease susceptibility and severity. Early-life viral infection causes acute illness and can be associated with the development of wheezing and asthma in later life. The most commonly detected viruses are respiratory syncytial virus (RSV), rhinovirus (RV), and influenza virus. In this review we explore the complete picture from epidemiology and virology to clinical impact and immunology. Three striking aspects emerge. The first is the degree of similarity: although the infecting viruses are all different, the clinical outcome, viral evasion strategies, immune response, and long-term sequelae share many common features. The second is the interplay between the infant immune system and viral infection: the immaturity of the infant immune system alters the outcome of viral infection, but at the same time, viral infection shapes the development of the infant immune system and its future responses. Finally, both the virus and the immune response contribute to damage to the lungs and subsequent disease, and therefore, any prevention or treatment needs to address both of these factors.

  • Novel influenza A(H1N1) in a pediatric health care facility in New York City during the first wave of the 2009 pandemic.

    Arch Pediatr Adolesc Med. 2010 Jan; 164(1): 24-30
    Miroballi Y, Baird JS, Zackai S, Cannon JM, Messina M, Ravindranath T, Green R, Della-Latta P, Jenkins S, Greenwald BM, Furuya EY, Graham PL, Sonnett FM, Platt S, Delamora P, Saiman L

    OBJECTIVE: To describe the burden of care experienced by our pediatric health care facility in New York, New York, from May 3, 2009, to July 31, 2009, during the novel influenza A(H1N1) pandemic that began in spring 2009. DESIGN: Retrospective case series. SETTING: Pediatric emergency departments and inpatient facilities of New York-Presbyterian Hospital. Patients Children presenting to the emergency departments with influenza-like illness (ILI) and children aged 18 years or younger hospitalized with positive laboratory test results for influenza A from May 3, 2009, to July 31, 2009. MAIN OUTCOME MEASURES: Proportion of children with ILI who were hospitalized and proportion of hospitalized children with influenza A with respiratory failure, bacterial superinfection, and mortality. RESULTS: When compared with the same period in 2008, the pediatric emergency departments experienced an excess of 3750 visits (19.9% increase). Overall, 27.7% of visits were for ILI; 2.5% of patients with ILI were hospitalized. Of the 115 hospitalized subjects with confirmed influenza A (median age, 4.3 years), 93 (80.9%) had underlying conditions. Four (3.5%) had identified bacterial superinfection, 1 (0.9%) died, and 35 (30.4%) were admitted to a pediatric intensive care unit; of these 35 patients, 11 had pneumonia and required mechanical ventilation, including high-frequency oscillatory ventilation (n = 3). CONCLUSIONS: At our center, 2.5% of children with ILI presenting to the emergency departments during the first wave of the 2009 novel influenza A(H1N1) pandemic were hospitalized. Of the 115 hospitalized children with confirmed influenza A, 9.6% had respiratory failure and 0.9% died. These findings can be compared with the disease severity of subsequent waves of the 2009 novel influenza A(H1N1) pandemic.

  • Responses to 2009 H1N1 vaccine in children 3 to 17 years of age.

    N Engl J Med. 2010 Jan 28; 362(4): 370-2
    Arguedas A, Soley C, Lindert K

  • Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial.

    JAMA. 2010 Jan 6; 303(1): 37-46
    Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M

    CONTEXT: In the ongoing influenza pandemic, a safe and effective vaccine against 2009 influenza A(H1N1) is needed for infants and children. OBJECTIVE: To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children. DESIGN, SETTING, AND PARTICIPANTS: Randomized, observer-blind, age-stratified, parallel group study assessing 2 doses of an inactivated, split-virus 2009 influenza A(H1N1) vaccine in 370 healthy infants and children aged 6 months to less than 9 years living in Australia. INTERVENTION: Intramuscular injection of 15 microg or 30 microg of hemagglutinin antigen dose of monovalent, unadjuvanted 2009 influenza A(H1N1) vaccine in a 2-dose regimen, administered 21 days apart. MAIN OUTCOME MEASURES: Hemagglutination inhibition assay to estimate the proportion of participants with antibody titers of 1:40 or greater, seroconversion, or a significant antibody titer increase, and factor increase in geometric mean titer. Assessments of solicited adverse events during 7 days and unsolicited adverse events for 21 days after each vaccination. RESULTS: Following the first dose of vaccine, antibody titers of 1:40 or greater were observed in 161 of 174 infants and children in the 15-microg group (92.5%; 95% confidence interval [CI], 87.6%-95.6%) and in 168 of 172 infants and children in the 30-microg group (97.7%; 95% CI, 94.2%-99.1%). Corresponding seroconversion rates were 86.8% (95% CI, 80.9%-91.0%) and 94.2% (95% CI, 89.6%-96.8%), and factor increases in geometric mean titer were 13.6 (95% CI, 11.8-15.6) and 18.3 (95% CI, 15.7-21.4). All participants demonstrated antibody titers of 1:40 or greater after the second vaccine dose. Immune responses were robust regardless of age, baseline serostatus, or seasonal influenza vaccination status. The majority of adverse events were mild to moderate in severity. CONCLUSION: One 15-microg dose of vaccine was immunogenic in infants and children starting at 6 months of age and vaccine-associated reactions were mild to moderate in severity. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00940108.

  • Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial.

    Pediatrics. 2010 Jan; 125(1): e35-51
    Carbonell-Estrany X, Simões EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA,

    OBJECTIVE: Palivizumab reduces respiratory syncytial virus (RSV) hospitalization in children at high risk by approximately 50% compared with placebo. We compared the efficacy and safety of motavizumab, an investigational monoclonal antibody with enhanced anti-RSV activity in preclinical studies, with palivizumab. METHODS: This randomized, double-blind, multinational, phase 3, noninferiority trial assessed safety and RSV hospitalization in 6635 preterm infants aged

  • Antiviral treatment and prophylaxis of influenza virus in children.

    Pediatr Ann. 2009 Dec; 38(12): 667-74
    Nayak JL, Treanor JJ

  • The daunting practicalities of in-office pediatric influenza vaccination: 2009-2010.

    Pediatr Ann. 2009 Dec; 38(12): 655-60
    Block SL

  • Guidance on novel influenza A/H1N1 in solid organ transplant recipients.

    Am J Transplant. 2010 Jan; 10(1): 18-25
    Kumar D, Morris MI, Kotton CN, Fischer SA, Michaels MG, Allen U, Blumberg EA, Green M, Humar A, Ison MG,

    Novel influenza A/H1N1 virus has caused significant illness worldwide. In response to this global crisis, the American Society of Transplantation (AST) Infectious Diseases Community of Practice and the Transplant Infectious Diseases section of The Transplantation Society (TTS) developed a guidance document for novel H1N1. In this paper, we discuss current guidance for H1N1 as it relates to solid organ transplantation. We include discussion around clinical presentation, diagnosis, therapy and prevention specifically addressing areas such as chemoprophylaxis, immunization and donor-derived infection. Although this document addresses conditions specific to novel H1N1, many principles could be applied to future pandemics. As new information emerges about novel H1N1, updates will be made to the electronic version of the document posted on the websites of the AST and TTS.

  • Trivalent inactivated influenza virus vaccine given to two-month-old children: an off-season pilot study.

    Pediatr Infect Dis J. 2009 Dec; 28(12): 1099-104
    Walter EB, Englund JA, Blatter M, Nyberg J, Ruben FL, Decker MD,

    BACKGROUND: Although children less than 6 months of age have the highest risk for hospitalization related to influenza infection, influenza vaccine is not approved for these children. METHODS: In an open-label, off-season study, healthy 6 to 12 week and 6-month-old children received 2 doses of the 2004 to 2005 trivalent inactivated influenza vaccine (TIV) administered 1 month apart along with other routine pediatric vaccines. Safety was assessed by parental diaries (n = 393). Immunogenicity analyses (n = 293) were performed on sera obtained before vaccination and 1 month after the second dose of TIV. Outcomes included the frequencies of subjects with injection site and systemic reactions and seroprotection rates to TIV antigens. RESULTS: Injection site reactions and fevers were generally mild and resolved within 3 days. Postvaccination seroprotection rates (titer > or = 1:40) in the 6- to 12-week-old and 6-month-old groups were 46% and 69% to A/New Caledonia (H1N1), 59% and 79% to A/Wyoming (H3N2), and 5% and 22% to B/Jiangsu (P < 0.001, all comparisons). For seronegative 6- to 12-week-olds whose mothers had not received TIV during pregnancy, postvaccination seroprotective titers to A/New Caledonia (H1N1) were achieved in 70% (38/54) and to A/Wyoming (H3N2) in 68% (23/34) of infants. CONCLUSIONS: TIV was well tolerated and safe when administered to children at both 6 to 12 weeks and 6 months of age. The antibody response was lower in the younger children, probably related to antibody suppression from passively acquired antibodies from mothers. In 6- to 12-week-olds without preexisting antibody, seroresponses to influenza A antigens approached those of 6-month-old children.

  • Tetracaine (ametop) compared to placebo for reducing pain associated with intramuscular injection of palivizumab (synagis).

    J Pediatr Nurs. 2009 Dec; 24(6): 529-33
    Newby BD, Faschoway GD, Soukoroff CI

    Infants receive many painful immunizations before they are 2 years old. The purpose of this study was to evaluate if topical tetracaine reduces the pain of intramuscular palivizumab compared to placebo. There were two study injections, one with tetracaine and one with placebo. Pain was scored by their parents and a pediatric nurse. Topical tetracaine was not associated with a significant reduction in pain score, although it did lead to faster recovery times. Additional pain-reduction strategies are required.

  • Efficacy of a single dose of live attenuated influenza vaccine in previously unvaccinated children: a post hoc analysis of three studies of children aged 2 to 6 years.

    Clin Ther. 2009 Oct; 31(10): 2140-7
    Block SL, Toback SL, Yi T, Ambrose CS

    BACKGROUND: Although 2 doses of influenza vaccine are recommended for children aged <9 years who have not been previously vaccinated, children may receive only 1 dose because of suboptimal adherence to national influenza vaccination recommendations. OBJECTIVE: This study evaluated the efficacy and tolerability of a single dose of the live attenuated influenza vaccine (LAIV) in previously unvaccinated children aged > or = 2 years, the population for which LAIV is approved. METHODS: This study was a post hoc subgroup analysis of previously published studies. Three randomized, double-blind, placebo-controlled clinical trials have evaluated the efficacy of a single dose of LAIV in previously unvaccinated young children. Single-dose efficacy, as a prespecified outcome, was evaluated in the subgroup of children aged 2 to 6 years. Reactogenicity and adverse events through 10 days after vaccination were reported after 1 and 2 doses. RESULTS: Across all studies combined, the mean (SD) ages of the children within the subgroups analyzed were 35.8 (12.1) months for LAIV recipients and 34.5 (11.3) months for placebo recipients. The groups were balanced by sex, with 51% and 50% boys in the LAIV and placebo groups, respectively. The LAIV and placebo groups were also balanced with regard to the countries of origin, as follows: United States (35% LAIV, 31% placebo), Southeast Asia (35% LAIV, 44% placebo), South America (19% LAIV, 15% placebo), and South Africa (11% LAIV, 11% placebo). In a post hoc subgroup analysis of children aged 2 to 6 years from these 3 studies, the efficacy of a single dose of LAIV compared with placebo was 71.5% (95% CI, 52.9% to 83.4%), 87.3% (95% CI, 59.2% to 96.1%), and 59.9% (95% CI, 31.1% to 77.4%). Two of the studies compared the efficacy of 1 and 2 doses of vaccine in the same season. The 1-dose efficacy of LAIV was 87% to 92% of the 2-dose efficacy. Upon revaccination in year 2 with a single dose, year-2 efficacy was not significantly different for children who received either 1 or 2 doses in year 1 (1 dose in year 1, efficacy 64.1% [95% CI, 13.1% to 85.7%]; 2 doses in year 1, efficacy 55.4% [95% CI, -23.6% to 85.9%]; P = NS). All reactogenicity events associated with the first dose of LAIV were decreased after the second dose, with the exception of cough. CONCLUSIONS: A single dose of LAIV provided significant but not optimal protection against influenza in previously unvaccinated children. This finding may be of particular importance for children who are at risk of being partially immunized.

  • Best practices in perinatal care: prevention and treatment of novel influenza A (H1N1) virus during pregnancy and the immediate postbirth period.

    J Perinat Neonatal Nurs. 2009 Oct-Dec; 23(4): 307-11
    Mahlmeister LR

  • Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in infants and children.

    Influenza Other Respi Viruses. 2009 Nov; 3(6): 315-25
    Nolan T, Richmond PC, McVernon J, Skeljo MV, Hartel GF, Bennet J, Basser RL

    OBJECTIVE: Few prospective studies of inactivated split virion influenza vaccine have been conducted in infants and children. Our objective was to evaluate the safety, reactogenicity and immunogenicity of a thimerosal-free inactivated influenza vaccine (Fluvax; CSL Limited, Parkville, Australia) in children aged 6 months to <9 years. METHODS: A prospective, open-label, phase III clinical trial was conducted in 298 healthy children previously unvaccinated with influenza, commencing in the Southern Hemisphere 2005 autumn. Participants were divided into two groups (Group A: > or =6 months to <3 years; Group B: > or =3 years to <9 years), and received two doses of the 2005 vaccine, and one dose of the 2006 vaccine one year later (Group A: 0.25 ml per dose; Group B: 0.5 ml per dose). Vaccine safety and reactogenicity was evaluated for 30 days after each dose. Immunogenicity was assessed using hemagglutination inhibition and single radial hemolysis assays. RESULTS: There were no withdrawals due to adverse events (AEs). The majority of solicited local and systemic AEs were of mild severity. A maximum intensity of severe was reported for injection site pain and fever by only 3.0% and 3.4% of participants, respectively. The vaccine was immunogenic for all antigens, with > or =95% of both younger and older children achieving seroprotection after dose 2. CONCLUSIONS: This thimerosal-free inactivated influenza vaccine had a favorable safety profile and was immunogenic in children aged > or =6 months and <9 years. Primary and booster vaccination produced consistently immunogenic responses including in children under 3 years of age receiving 0.25 ml doses of vaccine.

  • Antigen-based assays for the identification of influenza virus and respiratory syncytial virus: why and how to use them in pediatric practice.

    Clin Lab Med. 2009 Dec; 29(4): 649-60
    Principi N, Esposito S

    This article describes the clinical and socioeconomic relevance of influenza (IV) and respiratory syncytial virus (RSV) in pediatrics, the characteristics and limitations of currently available assays, and the impact of rapid diagnostic tests. This article shows that rapid tests for the detection and identification of IV and RSV in the respiratory secretions of infants and children are useful in the diagnosis of common, and possibly severe diseases, such as influenza and bronchiolitis. The tests' specificity and sensitivity make them most reliable when the prevalence of influenza or RSV infection is high, which suggests that their routine use should be restricted to the peak periods of viral circulation. The most recently marketed tests are similarly effective in identifying viruses, and so pediatricians should choose those that are less expensive, less time consuming, and easier to perform and to interpret.

  • Safety of influenza vaccination during pregnancy.

    Am J Obstet Gynecol. 2009 Dec; 201(6): 547-52
    Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA, Omer SB

    The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine influenza vaccination for all women who are or will be pregnant during the influenza season. During seasonal influenza epidemics, during previous pandemics, and with the current influenza A (H1N1) pandemic, pregnancy places otherwise healthy women at increased risk for serious complications from influenza, including death. Inactivated influenza vaccine can be safely and effectively administered during any trimester of pregnancy. No study to date has demonstrated an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated influenza vaccination. Moreover, no scientific evidence exists that thimerosal-containing vaccines are a cause of adverse events among children born to women who received influenza vaccine during pregnancy. In this article, we review the evidentiary basis for the recommendation of vaccination of all women who will be pregnant during the influenza season and safety data of influenza vaccination during pregnancy.

  • ASID (HICSIG) position statement: infection control guidelines for patients with influenza-like illnesses, including pandemic (H1N1) influenza 2009, in Australian health care facilities.

    Med J Aust. 2009 Oct 19; 191(8): 454-8
    Stuart RL, Cheng AC, Marshall CL, Ferguson JK,

    Standard and Droplet Precautions are considered adequate to control the transmission of influenza in most health care situations. Vaccination of health care staff, carers and vulnerable patients against seasonal and, eventually, pandemic influenza strains is an essential protective strategy. Management principles include: performance of hand hygiene before and after every patient contact or contact with the patient environment, in accord with the national 5 Moments for Hand Hygiene Standard; disinfection of the patient environment; early identification and isolation of patients with suspected or proven influenza; adoption of a greater minimum distance of patient separation (2 metres) than previously recommended; use of a surgical mask and eye protection for personal protection on entry to infectious areas or within 2 metres of an infectious patient; contact tracing for patient and health care staff and restriction of prophylactic antivirals mainly to those at high risk of severe disease; in high aerosol-risk settings, use of particulate mask, eye protection, impervious long-sleeved gown, and gloves donned in that sequence and removed in reverse sequence, avoiding self-contamination; exclusion of symptomatic staff from the workplace until criteria for non-infectious status are met; reserving negative-pressure ventilation rooms (if available) for intensive care patients, especially those receiving non-invasive ventilation; ensuring that infectious postpartum women wear surgical masks when caring for their newborn infants and practise strict hand hygiene; and implementation of special arrangements for potentially infected newborns who require nursery or intensive care.

  • Pandemic flu: a major concern for pregnant women.

    Nurs Womens Health. 2009 Oct; 13(5): 374-82
    Labant A, Greenawalt JA

    Nurses caring for pregnant women and infants are on the front lines to mitigate serious consequences that may occur with an influenza pandemic. To assist nurses in becoming prepared for a pandemic, this article will address various types of influenza viruses, effects of influenza on pregnant women, diagnosis, treatment and ways to protect pregnant women and newborns.

  • Vaccines for preventing influenza in people with cystic fibrosis.

    Cochrane Database Syst Rev. 2009; CD001753
    Dharmaraj P, Smyth RL

    BACKGROUND: Viral respiratory tract infections in people with cystic fibrosis (CF) have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for people with CF. OBJECTIVES: To assess the effectiveness of influenza vaccination for people with CF. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also contacted the companies which market the influenza vaccines used in the trials to obtain further information about randomised controlled trials.Date of the most recent search of the Cystic Fibrosis Trials Register: 05 March 2009. SELECTION CRITERIA: All randomised and quasi-randomised trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. Additional information was obtained by contacting the investigators when it was indicated. MAIN RESULTS: Four studies enrolling a total of 179 participants with CF (143 (80%) were children aged 1 to 16 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a subunit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and the other two studies compared a split virus to a subunit vaccine and a virosome to a subunit vaccine (all intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48 out of 201 participants (24%) for the intranasal live vaccine to 13 out of 30 participants (43%) for the split virus vaccine. With the limitation of a statistical low power there was no significant difference between the study vaccinations. None of the events were severe. All study influenza vaccinations generated a satisfactory serological antibody response. No study reported other clinically important benefits. AUTHORS' CONCLUSIONS: There is currently no evidence from randomised studies that influenza vaccine given to people with CF is of benefit to them. There remains a need for a well-constructed clinical study, that assesses the effectiveness of influenza vaccination on important clinical outcome measures.

  • Inactivated influenza vaccine effectiveness against influenza-like illness among young children in Japan--with special reference to minimizing outcome misclassification.

    Vaccine. 2009 Nov 23; 27(50): 7031-5
    Ochiai H, Fujieda M, Ohfuji S, Fukushima W, Kondo K, Maeda A, Nakano T, Kamiya H, Hirota Y,

    The aim of the present study was to investigate the influenza vaccine effectiveness among young children in Japan. Study subjects were recruited from 43 pediatric clinics. Influenza-like illness (ILI) was defined as an acute febrile illness with respiratory symptoms; ILI with a fever of > or =39 degrees C was considered to be severe ILI (SILI). The adjusted OR of vaccination significantly decreased to 0.75 for SILI. Influenza vaccination for young children had a protective effect on the occurrences of SILI. This study also indicated that three key tools (case surveillance with equal scrutiny, confining observation to the peak epidemic period, and adoption of strict criteria for ILI) could minimize outcome misclassification and thus provide adequate methodology for monitoring vaccine effectiveness without laboratory confirmation.