Stan L Block

University of Louisville, Louisville, Kentucky, United States

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Publications (31)89.05 Total impact

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    ABSTRACT: BACKGROUND:: Acute otitis media (AOM) is a frequent complication of influenza in children, and influenza vaccination helps protect against influenza-associated AOM. A live attenuated influenza vaccine (LAIV) approved for eligible children aged ≥2 years for the prevention of influenza also effectively reduces influenza-associated AOM. However, the annual effectiveness of LAIV against all-cause AOM is unknown. METHODS:: AOM rates in children 6-83 months of age from 6 randomized, placebo-controlled trials and 2 randomized, inactivated influenza vaccine (IIV)-controlled trials were pooled and analyzed. To enable comparison with studies of AOM prevention by pneumococcal conjugate vaccines (PCV), 12-month effectiveness was calculated assuming that LAIV had no effect outside of influenza seasons. RESULTS:: During influenza seasons, LAIV efficacy compared with placebo against all-cause AOM in children 6-71 months of age (N=9497) was 12.4% (95% CI: 2.0%, 21.6%) in year 1. In year 2, the efficacy in children aged 18-83 months (N=4142) was 6.2% (95% CI: -12.4%, 21.7%). Compared with IIV, the efficacy of LAIV in children 6-71 months (N=9901) against febrile all-cause AOM was 9.7% (95% CI: -2.1%, 20.1%). The estimated 12-month effectiveness of LAIV compared with placebo against all-cause AOM was 7.5% (95% CI: -2.4%, 16.2%). CONCLUSIONS:: LAIV reduced the incidence of all-cause AOM compared with placebo in children. The estimated 12-month effectiveness of LAIV was comparable with PCV7. The effects of the vaccines will overlap somewhat; however, because PCVs only prevent a fraction of all pneumococcal AOM and influenza-associated AOM can be caused by other pathogens, LAIV could further reduce the incidence of AOM in children.
    The Pediatric Infectious Disease Journal 12/2012; · 3.57 Impact Factor
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    ABSTRACT: Influenza B is responsible for significant morbidity in children and adults worldwide. For more than 25 years, two antigenically distinct lineages of influenza B viruses, B/Yamagata and B/Victoria, have cocirculated globally. Current influenza vaccine formulations are trivalent and contain two influenza subtype A strains (A/H1N1 and A/H3N2) but only one B strain. In a half of recent influenza seasons, the predominant circulating influenza B lineage was different from that contained in trivalent influenza vaccines. A quadrivalent live attenuated influenza vaccine (Q/LAIV) that contains two B strains, one from each lineage, has been developed to help provide broad protection against influenza B. Q/LAIV was recently approved for use in the USA in eligible individuals 2-49 years of age. This review summarizes clinical trial data in support of Q/LAIV.
    Expert Review of Vaccines 11/2012; · 4.22 Impact Factor
  • Steven Black, Stan L Block
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    ABSTRACT: Adolescents constitute a high-risk group for invasive meningococcal disease. MenACWY-CRM (Menveo, Novartis Vaccines, Cambridge, MA) is a quadrivalent meningococcal conjugate vaccine indicated to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y. It has been approved for use in persons age 2-55 years. The tolerability and immunogenicity of MenACWY-CRM in adolescents have been ascertained in phase 2 and 3 trials against MPSV4 (Menomune, sanofi pasteur, Swiftwater, PA), an unconjugated quadrivalent meningococcal vaccine, and MenACWY-D (Menactra, sanofi pasteur), another conjugated quadrivalent meningococcal vaccine. Clinical trials also have demonstrated that MenACWY-CRM is well tolerated and immunogenic when administered to adolescents concomitantly with the combined tetanus, diphtheria, and acellular pertussis vaccine (Boostrix, GlaxoSmithKline Biologicals, Rixensart, Belgium) and the quadrivalent human papillomavirus vaccine (Gardasil, Merck & Co., Inc., Whitehouse Station, NJ).
    Journal of Adolescent Health 09/2012; · 2.97 Impact Factor
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    ABSTRACT: The successful vaccination of children 6 to 36 months of age against 2009 A/H1N1 influenza was essential to help reduce the burden of pandemic disease in both the pediatric and adult populations. We compared the immunogenicity and safety of 4 alternative monovalent vaccine formulations to identify which provided optimal levels of seroprotection according to the US and European Union (EU) licensure criteria. A total of 654 healthy subjects (6 to <36 months old) were given 2 vaccine doses 3 weeks apart. Participants were assigned to 1 of the 4 immunization groups, receiving MF59-adjuvanted (Novartis Vaccines, Marburg, Germany) vaccine either containing 3.75 μg or 7.5 μg of A/H1N1 California/7/2009 antigen, or nonadjuvanted vaccine containing 7.5 μg or 15 μg of antigen. Antibody titers were assessed by hemagglutination inhibition assay 3 weeks, 3 months and 1 year after immunization. Vaccine safety was monitored throughout the study. After 1 dose, both adjuvanted formulations met the US and EU criteria for seroconversion; the 15 μg nonadjuvanted vaccine met the EU criterion for seroconversion alone. The US and EU criteria for seroprotection were only met by adjuvanted groups. MF59-adjuvanted formulations alone resulted in clinically significant persisting antibody titers after 12 months. All vaccines were well tolerated. A single dose of MF59-adjuvanted vaccine containing 3.75 μg A/H1N1 antigen was highly immunogenic, met both the US and EU licensure criteria and was well tolerated. These data support the suitability of this monovalent vaccine formulation for pandemic use in children 6 to <36 months of age.
    The Pediatric Infectious Disease Journal 04/2012; 31(7):e92-8. · 3.57 Impact Factor
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    ABSTRACT: Influenza B viruses from 2 lineages cocirculate annually. Because the single B strain contained in trivalent vaccines may not match the major circulating strain, adding a second B virus could enhance protection. This study compared the safety and immunogenicity of an investigational quadrivalent Ann Arbor strain live attenuated influenza vaccine (Q/LAIV) with that of 2 trivalent vaccines (T/LAIV), each containing a B strain from a different lineage. This randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared with T/LAIV in children 2-17 years of age by comparing postdose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or 1 of 2 T/LAIV vaccines. Those subjects who were 9-17 years of age received 1 dose, and those 2-8 years of age received 2 doses 1 month apart. Serum immune responses were evaluated 1 month after dose 1 (dose 2 for influenza vaccine-naive subjects aged 2-8 years). Q/LAIV was noninferior to T/LAIV: upper bounds for all four 95% confidence intervals for the postdose geometric mean titer ratios (T/LAIV divided by Q/LAIV) were ≤1.5, the predefined noninferiority margin. The overall seroresponse rates (4-fold rise) were comparable between treatment groups. Safety events were comparable, except that fever was more common after dose 1 in Q/LAIV subjects (5.1%) than in T/LAIV subjects (3.1%) 2-8 years of age. The immunogenicity of Q/LAIV was noninferior to that of T/LAIV in children aged 2-17 years; safety was also comparable. Q/LAIV may broaden the protection against influenza B strains provided by current trivalent influenza vaccines.
    The Pediatric Infectious Disease Journal 03/2012; 31(7):745-51. · 3.57 Impact Factor
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    ABSTRACT: The safety and immunogenicity of the cell-culture-derived seasonal trivalent influenza vaccine ([CCIV]; Optaflu) has been reported previously in adults and the elderly. In this study, we compared the safety, reactogenicity and immunogenicity of CCIV with a conventional egg-derived trivalent influenza vaccine (TIV) in a healthy pediatric population. A total of 3604 subjects were randomized to receive 2 doses of CCIV or TIV (3-8 years, n = 2630) at a 28-day interval or a single vaccination (9-17 years, n = 974). Antibody levels on days 1, 29 and 50 were measured by hemaglutination inhibition assay using egg-derived and cell-derived test antigens. Adverse reactions were solicited via memory aids for 7 days after each injection, and unsolicited adverse events/serious adverse events were collected for 6 months postvaccination. Noninferiority of CCIV versus TIV was demonstrated for most immunogenicity measures, particularly by using cell-derived antigen in the hemaglutination inhibition assay. In 3- to 8-year-olds (the primary objective), both CCIV and TIV met all 3 Committee for Medicinal Products for Human Use immunogenicity criteria for A/H1N1 and A/H3N2 strains. Lower immune responses were observed against the B strain, fulfilling Committee for Medicinal Products for Human Use criteria only for geometric mean ratio (TIV, CCIV) and seroconversion rate (TIV, CCIV [cell-derived antigen]). Both CCIV and TIV were safe and well tolerated, with no differences in local and systemic solicited reactions or in unsolicited adverse events/serious adverse events. CCIV produced in mammalian cell culture is a safe, well-tolerated and immunogenic alternative to conventional egg-derived influenza vaccines for children and adolescents.
    The Pediatric Infectious Disease Journal 02/2012; 31(5):494-500. · 3.57 Impact Factor
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    ABSTRACT: Trivalent seasonal influenza vaccines contain 2 A strains and 1 B strain. B strains of 2 antigenically distinct lineages, Yamagata and Victoria, have been co-circulating annually, and the B strain included in vaccines often has not been a lineage match to the major circulating strain. Thus, a vaccine containing B strains from both lineages could broaden protection against influenza. Quadrivalent live attenuated influenza vaccine (Q/LAIV) is an investigational 4-strain formulation of LAIV that contains 2 A strains, A/H1N1 and A/H3N2, and 2 B strains, 1 from each lineage. A randomized, double-blind, active-controlled study of Q/LAIV was conducted in 1800 adults aged 18-49 years to compare the immunogenicity and safety of Q/LAIV to trivalent LAIV (T/LAIV). Subjects were randomized 4:1:1 to receive an intranasal dose of Q/LAIV (n=1200) or 1 of 2 matching T/LAIV vaccines, each containing 1 of the B strains included in Q/LAIV (n=600 total). The primary endpoint was the comparison of the post-vaccination strain-specific geometric mean titers (GMT) of hemagglutination inhibition antibody in Q/LAIV recipients to those in T/LAIV recipients, with immunologic noninferiority of Q/LAIV to be demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) for the ratio of the GMTs [T/LAIV divided by Q/LAIV] was ≤1.5 for all strains. Q/LAIV met the criteria for noninferiority: the ratios of the GMTs for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 1.09 (95% CI, 1.01-1.18), 1.05 (95% CI, 0.96-1.14), 1.10 (95% CI, 0.97-1.25), and 0.92 (95% CI, 0.82-1.03), respectively. Solicited symptoms and adverse events were similar in the Q/LAIV and T/LAIV arms. Q/LAIV may confer increased protection against influenza by targeting B strains from both lineages.
    Vaccine 11/2011; 29(50):9391-7. · 3.77 Impact Factor
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    ABSTRACT: While annual influenza vaccination is recommended by the CDC for children 6 months and older, vaccination rates remain suboptimal. For healthy, US children 2 years of age and older, influenza vaccine is available as an intramuscular injection (TIV) or an intranasal spray (LAIV), respectively. Little is known about children's experiences and preferences for influenza vaccine attributes. To examine preferences for influenza vaccine attributes and their relative importance among children. A quantitative web-survey was administered to children aged 8-12 years sampled from a standing online panel representative of the US population. Children were stratified by age, gender and parent's influenza vaccination behavior. The survey included questions to ascertain children's preferences for influenza vaccine attributes, including efficacy, chance of common side effects, and mode of administration. It included conjoint (trade-off) questions in which children traded-off different attributes in their choice between two influenza vaccines with differing features. We also surveyed children's comprehension of and ability to complete the conjoint questions. 544 children completed the survey (response rate 37%). Children most frequently selected efficacy as the most important vaccine attribute followed by mode of administration (45% and 31%, respectively). When asked for their preference to receive influenza vaccine as a "shot" or a "nose spray", the majority (69%) preferred the nose spray. An evaluation of children's ability to complete the conjoint survey demonstrated that 85% of the sample was able to complete the conjoint tasks. Analysis of the conjoint responses demonstrated that mode of administration and efficacy had the greatest impact on preferences, with a relative importance of 40.5% and 30.6%, respectively. In a direct comparison of vaccine profiles representing the efficacy, side effects, and other characteristics of LAIV and TIV, 79% of children preferred the LAIV-like profile. Children in the sample had consistent opinions regarding influenza vaccine attributes and consider vaccine efficacy and mode of administration to be important. Children can be informed participants in influenza prevention and can be included in discussions regarding influenza vaccination.
    Vaccine 06/2011; 29(26):4334-40. · 3.77 Impact Factor
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    ABSTRACT: influenza vaccine must be distributed and administered each year during a limited time interval. To our knowledge, no previous studies have simultaneously evaluated the delivery and administration of privately purchased vaccines and influenza vaccines acquired through the Vaccines for Children (VFC) program. a prospective, observational study was conducted in US outpatient pediatric offices, tracking all influenza vaccinations during the season by age group, first or second vaccination, the child's need for 1 or 2 doses, type of vaccine, and VFC status. a total of 42 and 84 practices completed the study in 2007 to 2008 and 2008 to 2009, respectively. In both seasons, initial shipments of VFC influenza vaccine generally arrived 4 to 5 weeks later than non-VFC shipments; VFC vaccine administration also started 1 month later than administration of privately purchased vaccine. Vaccine administration peaked in early November and late October in years 1 and 2, respectively, and declined rapidly thereafter. Overall, approximately one-half of all children who required 2 doses of vaccine were estimated to have received 2 doses. In both years, 2-dose compliance rates in the VFC population were 17% to 19% lower than those in the non-VFC population, possibly resulting from the VFC population's shorter time interval for second dose receipt. the VFC program is critical to ensuring financially vulnerable children have access to vaccination. Manufacturers, distributors, and public health officials should deliver VFC influenza vaccine to providers as quickly as possible. Pediatric healthcare providers should increase efforts to vaccinate all populations, especially the VFC population, in later months.
    The Pediatric Infectious Disease Journal 02/2011; 30(2):100-6. · 3.57 Impact Factor
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    ABSTRACT: In this qualitative study we explored children's perceptions of influenza, preferences for influenza vaccines, and ability to understand "risk" of vaccine adverse effects and different attributes between injectable and intranasal vaccines. In-person, semi-structured interviews were conducted among 28 U.S. children aged 6 through 12 years. Many children understood the concept of influenza illness and believed vaccination was important. Efficacy, adverse effects, and mode of administration affected their preferences for influenza vaccines. Children 8 years of age and older were able to consider multiple attributes when selecting between hypothetical vaccines, and their responses were consistent with their previously stated preferences for individual attributes. Most children would prefer a nasal spray over a shot vaccine when all other vaccine attributes were equal. Efficacy, adverse effects, and mode of administration were important factors in children's preferences for influenza vaccine. Children as young as 8 years of age appeared to understand vaccine "risk" and were able to consider multiple attributes simultaneously when choosing between vaccine alternatives.
    Journal of Pediatric Health Care 01/2011; 25(3):171-9. · 1.76 Impact Factor
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    ABSTRACT: Influenza vaccine is available as an intramuscular injection or an intranasal spray for eligible children. This study was conducted to examine parents' preferences for influenza vaccine attributes and the attributes' relative importance regarding the vaccination of their children. A quantitative Web survey was administered to 500 parents of children aged 2 to 12 years. The survey included general preference questions and conjoint (trade-off) questions. Parents most frequently selected efficacy, risk of temporary side effects, and physician recommendation as important vaccine attributes from a provided list (92%, 75%, and 59%, respectively). For attributes selected as important, parents rated the importance of the attribute; the highest mean importance ratings were given to efficacy, presence of mercury-containing preservative, and physician recommendation.The highest relative importance ratings in the conjoint section were given to efficacy and presence of mercury-containing preservative. Parental education on influenza vaccine efficacy and safety may help to improve pediatric vaccination rates.
    Clinical Pediatrics 01/2011; 50(4):338-47. · 1.27 Impact Factor
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    ABSTRACT: An open-label study evaluated the safety (n = 53) and pharmacokinetics (n = 8) of single-dose therapy with 1500 mg famciclovir (prodrug of penciclovir) for recurrent herpes labialis in adolescents. Mean Cmax, mean AUC0-∞, and clearance for penciclovir were 9.37 μg/mL, 31.8 μg · h/mL, and 38.2 L/h, respectively, and within the range extrapolated from data in adults. Adverse events were generally mild and transient.
    The Pediatric Infectious Disease Journal 12/2010; 30(6):525-8. · 3.57 Impact Factor
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    ABSTRACT: In the United States, annual influenza vaccine is now recommended for all children 6 months through 18 years of age. This 2-year observational study of US outpatient pediatricians' offices captured office demographics and characteristics, recorded all influenza vaccinations administered and vaccination-related activities during the influenza season, and correlated office characteristics and activities associated with increased vaccine uptake. Offices generally offered the influenza vaccine from September through February and March; however, approximately 80% of vaccinations occurred in October through December. In 2008-2009 compared with 2007-2008, offices administered the vaccine earlier and later into the season. Estimated in-office rates of first-dose administration, 2-dose compliance, and use of the intranasal vaccine also increased. Qualitative analyses suggest that increased first-dose administration and 2-dose compliance rates are associated with smaller office size and a greater duration of vaccine availability, respectively, during both seasons.
    Clinical Pediatrics 10/2010; 49(10):954-63. · 1.27 Impact Factor
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    ABSTRACT: Acute otitis media (AOM) is a frequent complication of influenza in young children. Influenza vaccination is known to protect against AOM by preventing influenza illness. We sought to determine the efficacy of the live attenuated influenza vaccine (LAIV) against influenza-associated AOM compared with placebo and trivalent inactivated influenza vaccine (TIV). LAIV is approved for eligible children aged ≥ 2 years in the United States and in several other countries. AOM incidence data from 6 randomized, double-blind, placebo-controlled trials and 2 randomized, double-blind, TIV-controlled trials in children 6 to 83 months of age were pooled and analyzed. A total of 290 cases of AOM were identified in 24,046 study subjects. LAIV efficacy against influenza-associated AOM was 85.0% (95% confidence interval [CI], 78.3%-89.8%) compared with placebo and 54.0% (95% CI, 27.0%-71.7%) compared with TIV. Efficacy trended higher in those ≥ 24 months of age compared with those aged 6 to 23 months. In placebo-controlled trials, among children who acquired influenza despite vaccination, AOM was diagnosed in 10.3% of LAIV recipients and 16.8% of placebo recipients, representing a 38.2% (95% CI, 11.0%-58.2%) relative reduction in the development of AOM. In TIV-controlled studies, among subjects with breakthrough influenza illness, the proportions of LAIV and TIV recipients who developed AOM were similar. Children receiving LAIV had a high level of protection against influenza-associated AOM when compared with placebo or TIV. This was most evident in children older than 2 years, for whom LAIV is indicated. LAIV recipients who contracted breakthrough influenza illness despite vaccination developed AOM at a significantly lower rate than did unvaccinated children who developed influenza.
    The Pediatric Infectious Disease Journal 10/2010; 30(3):203-7. · 3.57 Impact Factor
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    ABSTRACT: Despite the recommendation from the Centers for Disease Control and Prevention that children between the ages of 6 months and 18 years be vaccinated against influenza annually, vaccination rates remain suboptimal. This study was conducted to explore factors that influence parents' decisions regarding influenza vaccination for children aged 2 to 12 years, to quantify the relative importance of these factors, to identify an appropriate theoretical model for illustrating the relationships among these factors, and to characterize parents by their likelihood of vaccinating their children against influenza. A quantitative Web-based survey was administered to a sample of parents from an online panel representative of the US population. Parents were stratified based on self-reported rates of their personal influenza vaccination (every year, sometimes, or never) and the age of their child (2-4 years or 5-12 years). The results were examined by parents' likelihood of vaccinating their child in the next year (high, medium, or low). Participants were asked to rank their agreement with statements representing various beliefs and perceptions about influenza and influenza vaccine on a scale from 1 = strongly agree to 5 = strongly disagree. Parents who indicated that they vaccinate their child every year were asked to select the drivers of their decision to vaccinate; parents who indicated that they never vaccinate their child were asked to select the barriers affecting their decision not to vaccinate; and parents who responded that they sometimes vaccinate their child were asked to select both the drivers and barriers affecting their decision. Participants were then asked to rank the importance of each driver or barrier on a scale from 1 = a little important to 5 = extremely important. Mean agreement ratings were calculated for parents' beliefs and perceptions about influenza and influenza vaccine and were compared across likelihood subgroups. Mean importance ratings of the drivers and barriers to vaccination were also calculated and compared across likelihood subgroups. The survey sample consisted of 500 parents; their mean (SD) age was 37.4 (6.82) years, 57.2% were female, and 78.2% were non-Hispanic white. Among those who reported that they vaccinated their child against influenza every year or sometimes, the major drivers of vaccination were prevention of influenza (95.1%), a doctor's recommendation (89.5%), and the desire to reduce influenza symptoms (83.3%). Among those who reported sometimes or never vaccinating their child against influenza, barriers to vaccination were more variable. The most common barriers were low perceived risk of influenza (46.0%), the perception that the vaccine caused influenza (44.0%), and side effects caused by the vaccine (36.6%). Distinct differences were found in beliefs and perceptions of influenza and influenza vaccine according to respondents' likelihood of vaccination. A high likelihood of vaccination was associated with a greater perceived threat of influenza and less concern about the efficacy and safety of the vaccine. Convenience was an important factor among parents with a medium likelihood of vaccination. The Health Belief Model was identified as an appropriate theoretical framework for illustrating the factors influencing parents' decision-making about influenza vaccination. Prevention of influenza, reduction of influenza symptoms, and doctor recommendation were the main drivers of parents' decision to vaccinate their child against influenza. Barriers to vaccination were more variable and primarily included the risk of adverse effects and the perceived low risk of influenza. Increasing parents' awareness of the threat of influenza and the efficacy and safety of the vaccine, as well as improving the convenience of getting vaccinated, may help improve rates of pediatric influenza vaccination.
    Clinical Therapeutics 08/2010; 32(8):1448-67. · 2.23 Impact Factor
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    ABSTRACT: Data from 5 atomoxetine trials in pediatric outpatients with attention-deficit/hyperactivity disorder (ADHD) were divided into training and validation data sets to develop models predicting atomoxetine treatment response, using changes in individual ADHD Rating Scale (ADHD-RS) items early in treatment. Treatment response was predicted after 1 week by a > or =1-point score decrease in ADHD-RS item 15 ("easily distracted;" positive predictive values [PPVs]: 84.9%, 74.3%, and 73.3%; negative predictive values [NPVs]: 52.6%, 50.5%, and 46.3%; training and 2 validation data sets, respectively); after 2 to 3 weeks, by a > or =1-point score decrease in ADHD-RS item 1 ("fails to give close attention or makes careless mistakes;" PPV = 77.7% and 77.9%) and by the absence of a > or =1-point score decrease on ADHD-RS items 1 and 10 ("on the go;" NPV = 72.2% and 77.5%), or by the combination of items 1 and 10 (PPVs: 75.1% and 75.4%; NPVs: 72.2% and 77.5%; training and validation data sets, respectively).
    Clinical Pediatrics 08/2010; 49(8):768-76. · 1.27 Impact Factor
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    ABSTRACT: Multinational phase III trials of a human papillomavirus vaccine, Gardasil, have shown the vaccine to be generally well-tolerated, efficacious, and immunogenic. We evaluated the immunogenicity and safety of Gardasil administered concomitantly with Menactra and Adacel. In this open-label study, boys (n = 394) and girls (n = 648) aged 10 to 17 were randomly assigned in a 1:1 ratio as follows: group A (concomitant administration) received a 0.5-mL dose of Gardasil at day 1, month 2, and month 6 and a 0.5-mL dose of Menactra and Adacel on day 1; group B (nonconcomitant administration) received Gardasil at day 1, month 2, and month 6 and Menactra and Adacel at month 1. Antibody levels for all vaccine components were measured. Systemic, injection-site, and serious adverse experiences (AEs) were monitored. Immune responses after concomitant administration of the 3 vaccines were noninferior to nonconcomitant administration. Seroconversion for Gardasil was > or = 99% in both groups A and B. For Menactra and Adacel, concomitant administration of the vaccines was demonstrated to be noninferior to nonconcomitant administration. Concomitant administration was generally well-tolerated. No participants withdrew because of an AE. One serious AE of transient muscular weakness of <24 hours' duration after the third Gardasil injection was reported in group B and was deemed possibly vaccine-related by the investigator. Overall, concomitant administration was generally well-tolerated and did not interfere with the immune response to the respective vaccines. Concomitant administration should minimize the number of visits required to deliver each vaccine individually, leading to increased compliance and more effective disease prevention.
    PEDIATRICS 06/2010; 125(6):1142-51. · 4.47 Impact Factor
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    ABSTRACT: Acute otitis media (AOM) is the most common complication of pediatric influenza, and imposes a substantial health care burden. We examined the influence of oseltamivir treatment on the incidence and course of AOM in children with influenza. In the original study, 695 children 1-12 years who presented within 48h of the onset of influenza-like symptoms were randomized to oseltamivir (2mg/kg) or placebo given twice daily for 5 days. AOM was assessed at enrollment and days 3, 6 (+/-1), 10 (+/-2) and 28 (+/-7). AOM was clinically diagnosed by the participating primary care provider, supported by tympanometry when possible. We performed a retrospective analysis of those participants with laboratory-confirmed influenza (LCI). Assessments included the incidence and clinical course of new AOM cases. In all, 452 children had LCI; 217 received oseltamivir and 235 placebo. AOM was diagnosed on or after study day 3 at a significantly lower frequency in the oseltamivir versus placebo group (12.4% versus 21.7%; relative risk [RR]: 0.57 [95% CI: 0.37, 0.88], respectively). Treatment effects were greatest for children 1-2 years (RR=0.42 [95% CI: 0.20, 0.89]) and 3-5 years (RR=0.45 [95% CI: 0.19, 1.04]), in whom the incidence of AOM was highest. Oseltamivir treatment significantly reduces the emergence of new AOM infections in children with LCI; effects are most pronounced in those <5 years. Clinical trial number: WV15758.
    International journal of pediatric otorhinolaryngology 04/2010; 74(6):684-8. · 0.85 Impact Factor
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    ABSTRACT: Background: We describe the safety of the human papillomavirus (HPV)-6/11/16/18 vaccine using updated clinical trial data (median follow-up time of 3.6 years) and summarize up to 3 years of post-licensure surveillance. Methods: In 5 clinical trials, 21,480 girls/women aged 9 to 26 years and boys aged 9 to 16 years received ≥1 dose of HPV-6/11/16/18 vaccine or placebo. All serious and nonserious adverse experiences (AEs) and new medical conditions were recorded for the entire study period(s). As of June 2009, >25 million doses of HPV-6/11/16/18 vaccine had been distributed in the United States with >50 million doses globally. Post-licensure safety as summarized by the Centers for Disease Control and Prevention using the United States Vaccine Adverse Event Reporting System database is also reported. Results: Eight subjects experienced a treatment-related serious AE (0.05% vaccine; 0.02% placebo). Of 18 deaths (0.1% vaccine; 0.1% placebo), all were considered unrelated to study treatment. New medical conditions which were potentially consistent with autoimmune phenomena were reported in 2.4% of both vaccine and placebo recipients. Pain, the most common injection-site AE, occurred more frequently with vaccine (81% vaccine; 75% placeboaluminum; 45% placebo-saline). No differences were seen in the incidence of the most common nonserious AEs–headache and pyrexia. The Vaccine Adverse Event Reporting System has received 14,072 reports for the HPV-6/11/16/18 vaccine since licensure, with only 7% being serious AEs, about half the average reported for licensed vaccines in general. Conclusions: HPV-6/11/16/18 vaccination was associated with more injection-site pain than placebo but similar incidences of systemic and serious AEs and new medical conditions potentially consistent with autoimmune phenomena. Based on review of post-licensure safety information, the benefits of vaccination to prevent the majority of genital tract precancers and cancers continue to far outweigh its risks.
    The Pediatric Infectious Disease Journal 01/2010; 29(2):95-101. · 3.57 Impact Factor
  • Value in Health 01/2010; 13(3). · 2.19 Impact Factor

Publication Stats

583 Citations
89.05 Total Impact Points

Institutions

  • 2012
    • University of Louisville
      Louisville, Kentucky, United States
    • University of Turku
      Turku, Province of Western Finland, Finland
    • Cincinnati Children's Hospital Medical Center
      • Department of Pediatrics
      Cincinnati, OH, United States
  • 2010–2011
    • Oxford Outcomes
      Oxford, England, United Kingdom
  • 2008
    • Aurora St. Luke's Medical Center
      Milwaukee, Wisconsin, United States