Oral GS-5806 activity in a respiratory syncytial virus challenge study.

Background: Respiratory syncytial virus (RSV) is a common cause of infant hospitalizations and is increasingly recognized as a cause of considerable morbidity and mortality. No accepted antiviral treatment exists.

Methods: We conducted a double-blind, placebo-controlled study of GS-5806, an oral RSV-entry inhibitor, in healthy adults who received a clinical challenge strain of RSV intranasally.

Factors associated with in-office influenza vaccination by U.S. pediatric providers.

Background: In the United States, influenza vaccination is recommended for all children 6 months and older; however, vaccination rates are below target levels. A broad sample of U.S.

A postlicensure evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 24-59 months of age.

Background: In the United States, live attenuated influenza vaccine (LAIV) was initially approved for use in individuals aged 5-49 years in 2003, which was extended to individuals aged 2-49 years in 2007. At that time, a postlicensure commitment was made to describe the safety of LAIV within a cohort of eligible children aged 2-5 years.

Methods: A prospective observational postmarketing study was conducted to evaluate the safety of LAIV.

Improved timing of availability and administration of influenza vaccine through the US Vaccines for Children Program from 2007 to 2011.

The Vaccines for Children (VFC) program distributes one half of all vaccines administered to US children. Compared with commercial vaccine distribution, VFC distribution is more complex. This prospective observational study compares the delivery and administration of VFC versus non-VFC influenza vaccine in US pediatricians' offices across 3 influenza seasons and its apparent impact on 2-dose compliance rates.

Effectiveness of intranasal live attenuated influenza vaccine against all-cause acute otitis media in children.

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.

Quadrivalent Ann Arbor strain live-attenuated influenza vaccine.

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.

A US postmarketing evaluation of the frequency and safety of live attenuated influenza vaccine use in nonrecommended children younger than 5 years: 2009-2010 season.

The 2007 US approval for use of Ann Arbor strain live attenuated influenza vaccine (LAIV) in children aged 24 through 59 months included precautions against use in (1) children <24 months and children aged 24 through 59 months with (2) asthma, (3) recurrent wheezing, and (4) altered immunocompetence. Results from the third season (2009-2010) of a 3-year study postmarketing commitment to monitor LAIV vaccination rates and frequency of hospitalizations or emergency department visits within 42 days after LAIV are reported here. As in the first 2 seasons, LAIV usage in cohorts 1, 2, and 4 were low relative to those in LAIV-recommended populations.

In-office influenza vaccination by US pediatric providers varies greatly and is higher among smaller offices.

During the 2010-2011 US influenza season, 105 pediatric and 13 family practice offices participated in a prospective observational study of in-office influenza vaccination of children. Office characteristics, influenza vaccinations, and vaccination-related activities were reported. Among pediatric offices, first dose vaccination rates (2% to 60%), 2-dose compliance (11% to 100%), the duration of vaccine availability (60-302 days), and office visit type (well vs sick vs clinic) used for vaccinations varied greatly.

A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in adults 18-49 years of age.

Background: The Ann Arbor strain-live attenuated influenza vaccine (LAIV) was licensed in 2003 for use in the United States for individuals aged 5-49 years of age. As part of a postmarketing commitment to safety, LAIV was studied in adults 18-49 years participating in the Kaiser Permanente Health Plan over 5 influenza seasons.

Methods: Individuals received LAIV as part of routine care from October 2003 through March 2008.

A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age.

Background: Live attenuated influenza vaccine (LAIV) was licensed in 2003 in the United States for use in individuals aged 5-49 years.

Methods: A prospective observational postmarketing study was conducted to evaluate the safety of LAIV. Rates of medically attended events (MAEs) and serious adverse events (SAEs) in eligible children aged 5-17 years receiving LAIV as part of routine care from October 2003 to March 2008 were compared with rates in nonrandomized self, matched unvaccinated, and matched trivalent inactivated influenza vaccine (TIV)-vaccinated controls.

Clinical guidance on the use of live attenuated influenza vaccine after inadvertent freezing and warming.

The immediate and long-term impact of temperature deviations that may occur in clinical practice on live attenuated influenza vaccine (LAIV) potency was examined in four distinct studies that exposed vaccine to freeze/thaw cycles, warming, and heating conditions. No significant loss of vaccine potency was observed after three freeze/thaw cycles, warming of vaccine to 15°C (59°F) for 72 hours or less, exposure to room temperature (25°C/77°F) for 12 hours or less, or after heating to 37°C (99°F) for 6 hours or less. The results of these studies demonstrate that LAIV potency can potentially be maintained after exposure to temperature deviations.

A multi-season national estimate of adult influenza vaccination by U.S. office-based pediatricians, 2006-2011.

There is no national estimate of adult influenza vaccination by U.S. office-based pediatricians.

Maternal outcomes among pregnant women receiving live attenuated influenza vaccine.

Background: Although the live attenuated influenza vaccine (LAIV) prescribing information contains warnings/precautions against use during pregnancy, administration of LAIV to pregnant women does occur. Data regarding maternal outcomes after LAIV administration during pregnancy are limited.

Objectives: Maternal outcomes after LAIV vaccination during pregnancy were examined.

A postmarketing evaluation of the frequency of use and safety of live attenuated influenza vaccine use in nonrecommended children younger than 5 years.

The 2007 US approval for use of live attenuated influenza vaccine (LAIV) in children aged 24-59 months included precautions against use in (1) children <24 months and children aged 24-59 months with (2) asthma, (3) recurrent wheezing, and (4) altered immunocompetence. A postmarketing commitment was initiated to monitor LAIV use and the frequency of select safety outcomes in these cohorts. Vaccination rates and the frequency of hospitalizations or emergency department visits within 42 days after LAIV and trivalent inactivated influenza vaccine (TIV) administration were estimated from 2007 to 2009 claims data from a health insurance database.

Children's perceptions of influenza illness and preferences for influenza vaccine.

Introduction: 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.

Method: In-person, semi-structured interviews were conducted among 28 U.S.

Trends in U.S. pediatric influenza vaccination from 2006 to 2010 among children with private insurance.

In the United States, recommendations for the annual influenza vaccination of children have expanded significantly in recent years. Additionally, to facilitate influenza vaccination delivery by providers, recent recommendations have encouraged vaccination as soon as vaccine is available and throughout the influenza season. However, until now, there have been limited data published describing pediatric providers' responses to these recent recommendations.

Influenza vaccination of parents and guardians by US pediatricians.

In the 2008-2009 and 2009-2010 influenza seasons, 84 pediatric offices participating in a prospective observational study were surveyed about whether the office offered influenza vaccine to parents and guardians of pediatric patients. Each season, approximately half of all offices cited offering seasonal influenza vaccine to parents. In 2008-2009, reported barriers to parental vaccination included reimbursement, medicolegal concerns, and logistics.

The efficacy of live attenuated influenza vaccine against influenza-associated acute otitis media in children.

Background: 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).

Parents' decision-making regarding vaccinating their children against influenza: A web-based survey.

Background: 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.

Objectives: 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.

Methods: A quantitative Web-based survey was administered to a sample of parents from an online panel representative of the US population.

Timing of the availability and administration of influenza vaccine through the vaccines for children program.

Background: 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.

Methods: 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 prospective observational study of US in-office pediatric influenza vaccination during the 2007 to 2009 influenza seasons: use and factors associated with increased vaccination rates.

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.

Efficacy of live attenuated influenza vaccine in children 6 months to 17 years of age.

Background: It has been suggested that live attenuated influenza vaccine (LAIV) may be less effective in older individuals because of prior wild-type influenza infections. LAIV is currently approved in the United States, South Korea and Hong Kong for individuals 2-49 years of age.

Objective: To examine data from previously published pediatric studies to determine the efficacy of LAIV in various age groups.

Improving influenza vaccination rates in the workplace: a randomized trial.

Background: To minimize absenteeism resulting from influenza, employers frequently offer on-site influenza vaccination to employees. Yet the level of uptake of vaccine is low among working adults. This study was designed to increase workplace influenza vaccination rates by offering both a choice of intranasal (LAIV) and injectable (TIV) influenza vaccines to eligible employees, and an incentive for being vaccinated, and by increasing awareness of the vaccine clinic.

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.

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.