Stan L Block

University of Louisville, Louisville, Kentucky, United States

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Publications (73)191.56 Total impact

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    ABSTRACT: We present a long-term safety, immunogenicity, and effectiveness study of a quadrivalent human papillomavirus (HPV4) vaccine.
    Pediatrics. 08/2014;
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    ABSTRACT: To ensure adequate protection from seasonal influenza in the US, the Advisory Committee on Immunization Practices recommends vaccination of all persons aged 6 months or older, with rare exceptions. It also advises starting vaccination as soon as available and continuing throughout the influenza season. This study examined US seasonal vaccination trends during five consecutive influenza seasons in privately-insured children and adults.
    Vaccine. 07/2014;
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    ABSTRACT: Background: In 2008, the US Advisory Committee on Immunization Practices (ACIP) recommended universal pediatric influenza vaccination for children ≥ 6 months of age. CDC monitors overall influenza vaccination coverage based on systematic surveys, but little is known about trends in pediatric influenza vaccination by private payers. Methods: To describe seasonal influenza vaccination trends among commercially insured children(≤ 18 y.o.) in the U.S., we conducted a retrospective observational cohort study using administrative claims data from a large national insurer. Trends were examined based on current procedural terminology and generic product identifier codes for seasonal influenza vaccines during 2007-08 through 2011-12 seasons. Denominators were the number of children enrolled in the plan for 24 months: 12 months prior and 12 months after 1 July. Office visits were calculated 12 months prior to 1 July. Results: The denominators fluctuated by season and ranged between n=1,277,502 and n=1,363,087. Children <24 months had the highest likelihood to be vaccinated against influenza (47%-55%), and this likelihood decreased with older age (Figure 1). Geographically, children in the Northeast had the highest and children in the West had the lowest likelihood to be vaccinated. However, the differences by region were small (6-8 percentage points), Figure 2. Children with frequent office visits had higher likelihood of seasonal vaccination than those with few office visits (Figure 3). However, the likelihood of vaccination in those with ≥ 6 office visits was still low: 25%-35%. Only 2.4%-5.3% of children with no office visit were vaccinated against influenza. Conclusion: Younger children had a higher likelihood of influenza vaccination than older children. Rates of pediatric vaccination against seasonal influenza remain relatively low. Alternative venues for delivering seasonal influenza vaccines to children should be considered. Figure 1. Percentage vaccinated children by age. Figure 2. Percentage of vaccinated children by region. Figure 3. Percentage of vaccinated children, by the number of office visits the year prior to vaccination season. Evgeniya Antonova, MS, PhD1, David Kern, MS2, Stan Block, MD3,4, Herve Caspard, MD, ScD5, Ozgur Tunceli, PhD2 and Christopher Ambrose, MD5, (1)Medimmune, LLC, Gaithersburg, MD, (2)Health Core, Inc, Wilmington, DE, (3)University of Louisville, Louisville, KY, (4)University of Kentucky, Lexington, KY, (5)MedImmune, LLC, Gaithersburg, MD Disclosures: E. Antonova, MedImmune, LLC: Employee, Salary D. Kern, None S. Block, None H. Caspard, MedImmune: Employee, Salary O. Tunceli, None C. Ambrose, MedImmune: Employee, Salary
    IDWeek 2013 Meeting of the Infectious Diseases Society of America; 10/2013
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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
  • Stan L Block
    Pediatric Annals 11/2012; 41(11):452-5. · 0.30 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: Background: Acute otitis media (AOM) is a frequent complication of viral infections, including influenza, in young children. Live attenuated influenza vaccine (LAIV) has been shown to help protect against influenza-associated AOM by preventing influenza illness and decreasing the severity of breakthrough influenza illness. LAIV is approved for children 2–17 years of age and is not approved for use in children <24 months of age. Objectives: To estimate the efficacy of LAIV against AOM due to all causes in young children during the influenza season compared with placebo and trivalent inactivated influenza vaccine (TIV) Methods: All-cause AOM incidence for the entire influenza season was calculated for 5 randomized, double-blind, placebo-controlled trials in children 6–47 months of age (LAIV, n=6587; placebo, n=4905) and 2 randomized, double-blind, TIV-controlled trials in children 6–71 months of age (LAIV, n=4966; TIV, n=4971). AOM was diagnosed clinically by the demonstration of a visually abnormal tympanic membrane (with regard to color, position, and/or mobility) suggesting effusion, concomitantly with symptoms of an acute infection. Results: All-cause AOM during the influenza season was diagnosed more frequently in placebo recipients 6–23 months of age than in those 24–47 months of age (15.4% vs 12.3%; P=0.002). The pooled efficacy of LAIV in children 6–71 months of age against all-cause AOM was 16.4% (P<0.001) vs placebo and 9.5% (P=0.02) vs TIV. In children ≥24 months of age, LAIV efficacy against all-cause AOM in the season following vaccination was 20.5% (P=0.007) vs placebo and 7.5% (P=0.29) vs TIV. Conclusions: Among children 6–71 months of age, LAIV substantially reduced the incidence of all-cause AOM during the influenza season compared with placebo and TIV. Sponsored by MedImmune, LLC.
    1st National Immunization Conference Online 2012 Centers for Disease Control and Prevention; 03/2012
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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: Background: Seasonal influenza vaccines contain 3 strains, A/H1N1, A/H3N2 and B. Because B strains of 2 antigenically distinct lineages (Yamagata and Victoria) have been cocirculating, a vaccine containing 2 B strains could broaden protection against B strains. Methods: In March 2010, 2312 US children 2–17 years old were randomized 3:1:1 (blinded) to receive Q/LAIV or one of 2 T/LAIVs containing either a B Victoria (B-V) or B Yamagata (B-Y) strain (all strains matching those of Q/LAIV). The primary objective of the study was to demonstrate the immunologic noninferiority of Q/LAIV compared with T/LAIV by comparing the post-dose strain-specific geometric mean titers (GMTs) of hemagglutination inhibition (HAI) antibodies (expressed as reciprocal dilution). Subjects 9–17 years received 1 dose of vaccine. Subjects 2–8 years received 2 doses 1 month apart. Blood was obtained 1 month after dose 1 except in seasonal influenza vaccine-naive subjects 2–8 years old, in whom it was obtained after dose 2. Solicited symptoms were collected days 0–14 after each dose, adverse events (AEs) days 0–28 after each dose and serious AEs (SAEs) days 0–180 after last dose. Results: Q/LAIV was immunologically noninferior to T/LAIV, because the upper bounds of all four 95% confidence intervals (CIs) for post-dose strain-specific GMT ratios were ≤1.5, the predefined noninferiority margin. Post Dose Ratio of HAI Antibody GMTs Q/LAIV T/LAIV GMT Ratio (T/LAIV÷Q/LAIV) Strain N GMT N GMT Ratio 95% CI A/H1N1 1327 16.7 883 17.9 1.07 0.98, 1.16 A/H3N2 1327 27.7 883 28.8 1.04 0.94, 1.14 B Yamagata 1327 49.6 445 59.8 1.21 1.07, 1.37 B Victoria 1327 35.4 437 37.0 1.05 0.93, 1.18 Data from 2 T/LAIV arms were combined for A strains. Seroconversion rates (4-fold rise) in all subjects were comparable in both groups (Q/LAIV vs T/LAIV): 6.3% and 8.2% for A/H1N1; 3.9% and 3.6% for A/H3N2; 43.4% and 44.9% for B-Y; and 39.1% and 38.4% for B-V. Rates of solicited symptoms (SS) and AEs were comparable between Q/LAIV and T/LAIV. The largest rate difference (Q/LAIV-T/LAIV) in SS was for fever ≥38°C (1.8%). There were no related SAEs. Conclusion: The immunogenicity of Q/LAIV was noninferior to that of T/LAIV in children 2–17 years of age. Safety was comparable between study arms. Sponsored by MedImmune, LLC
    Infectious Diseases Society of America 2011 Annual Meeting; 10/2011
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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: 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 05/2011; 25(3):171-9. · 1.76 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: 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

Publication Stats

2k Citations
191.56 Total Impact Points

Institutions

  • 2001–2014
    • University of Louisville
      Louisville, Kentucky, United States
  • 2012–2013
    • MedImmune, LLC
      Maryland, 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
  • 1999
    • Creighton University
      Omaha, Nebraska, United States