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Pregnant women are recommended to receive inactivated influenza vaccination anytime during pregnancy. Studies have investigated the impact of influenza vaccination during pregnancy on birth outcomes and results on preterm birth have been inconsistent.We conducted a retrospective cohort study among children born at a gestational age≥24weeks from January 1, 2010 to December 31, 2015 at Kaiser Permanente...
To investigate whether there is a difference in the risk of asthma exacerbations between children with pre-existing asthma who receive live attenuated influenza vaccine (LAIV) compared with inactivated influenza vaccine (IIV).We identified IIV and LAIV immunizations occurring between July 1, 2007 and March 31, 2014 among Kaiser Permanente Northern California members aged 2 to <18years with a history...
We describe the establishment of a dynamic database linking mothers to newborns with the goal of studying vaccine safety in both pregnant women and their children and provide results of a study utilizing this database as a proof of concept.All Kaiser Permanente Northern California (KPNC) live births and their mothers were eligible for inclusion in the pregnancy database. We used the medical record...
The combination DTaP-IPV/Hib vaccine was licensed in the United States in 2008 for children ages 6weeks through 4years with doses administered at 2, 4, 6, and 15–18months of age. The aim of this study was to assess the safety of DTaP-IPV/Hib vaccine routinely administered as part of clinical care to infants at Kaiser Permanente Northern California.This was an observational, retrospective study that...
Large healthcare databases maintained by health plans have been widely used to conduct customized protocol‐based epidemiological safety studies as well as targeted routine sequential monitoring of suspected adverse events for newly licensed vaccines. These databases also offer a rich data source to discover vaccine‐related adverse events not known prior to licensure using data mining methods, but...
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.A prospective observational postmarketing study was conducted to evaluate...
Zostavax™ is a live, attenuated varicella-zoster virus vaccine indicated for the prevention of herpes zoster (shingles). An observational post-licensure (Phase IV) study was conducted at Kaiser Permanente Northern California (KPNC), a US managed care organization, to assess the safety of zoster vaccine in people 60 years of age or older, vaccinated in routine medical care.We performed a cohort study,...
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.Individuals received LAIV as part of routine care from October 2003 through March 2008...
Live attenuated influenza vaccine (LAIV) was licensed in 2003 in the United States for use in individuals aged 5–49 years.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...
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