Risk of medically attended local reactions following diphtheria toxoid containing vaccines in adolescents and young adults: A Vaccine Safety Datalink study

ArticleinVaccine 27(36):4912-6 · July 2009with6 Reads
DOI: 10.1016/j.vaccine.2009.06.038 · Source: PubMed
Abstract
Three vaccines currently recommended for adolescents (Tdap, Td, and MCV4 meningococcal conjugate vaccine) contain diphtheria toxoid. While the safety of individual diphtheria toxoid containing vaccines has been evaluated, less is known regarding the safety of administration of two or more of these vaccines, either concomitantly or sequentially. This study evaluated the risk of medically attended local reactions in adolescents and young adults with varying patterns of receipt of diphtheria toxoid containing vaccines. In general the risk of medically attended local reactions was low and did not differ with concomitant or sequential administration of diphtheria toxoid containing vaccines.
    • "Prespecified events that had been studied in other VSD studies of Tdap in adolescent and adult populations were included [13, 14]. Events of interest were identified by diagnoses that were coded according to the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Published data on the safety of tetanus-diphtheria-acellular pertussis vaccine (Tdap) in persons aged ≥65 years are limited. This study aims to examine a large cohort of Tdap users ≥65 years for evidence of increased risk of adverse events following vaccination. Methods: A matched cohort study design and a self-controlled case series (SCCS) design were used. The study population was adults aged ≥65 years who received the Tdap or tetanus and diphtheria (Td) vaccine during 1 January 2006-31 December 2010 at 7 health maintenance organizations in the United States. Seven major groups of prespecified events were identified electronically by diagnostic codes. Results: The study included 119 573 Tdap vaccinees and the same number of Td vaccinees. The results indicated that the risk of the prespecified events following Tdap was comparable to that following Td vaccination in this elderly population. There was a small increased rate of codes suggesting medically attended inflammatory or allergic events in 1-6 days following Tdap in the SCCS analysis (incidence rate ratio, 1.59 [95% confidence interval, 1.40-1.81]). Conclusion: Although there is a small increased risk of medically attended inflammatory or allergic events in 1-6 days following Tdap compared to other time periods, it is no more common than that following Td. This study provides empirical safety data suggesting that immunizing adults aged ≥65 years with Tdap to reduce the risk of pertussis in the elderly and their contacts should not have untoward safety consequences.
    Article · Nov 2012
  • [Show abstract] [Hide abstract] ABSTRACT: Tetanus-diphtheria-acellular pertussis (Tdap) was licensed in the United States in 2005 to be given in place of tetanus-diphtheria (Td) for single use in adolescents. This analysis was conducted to determine vaccination coverage with Td and Tdap among adolescents in the United States aged 13 to 17 years and to characterize adolescents who had not received a tetanus-containing booster vaccine. Data were analyzed from the National Immunization Survey-Teen (NIS-Teen) 2007, a random-digit-dialing telephone survey that is weighted to be nationally representative of adolescents aged 13 to 17 years. Parents gave verbal consent so that vaccination providers could be contacted to obtain the adolescents' immunization histories. Weighted coverage of Td and Tdap vaccines was estimated with bivariate analysis from returned vaccination data from the providers' records. A multivariable analysis was conducted to determine factors independently associated with nonreceipt of tetanus-containing vaccines. Missed opportunities for vaccination with Td or Tdap were determined from documented vaccination visits for other vaccines. Out of 69,289 households screened, 6572 had an eligible adolescent aged 13 to 17 years and 5486 (83.5%) completed the household interview. Among 5474 adolescents who met the age criterion and completed a household interview, consent to contact providers was obtained for 4114 (75.2%). A total of 2947 adolescents (53.7% of those with completed household interviews) had immunization histories returned from providers for verification. In 2007, a total of 2149 adolescents (weighted percentage, 72.3%) aged 13 to 17 years had received at least one tetanus booster since age 10 years; Tdap coverage was 30.4%. The mean (SE) age at Td or Tdap receipt was 13.04 (0.04) years (range, 10.00-17.84 years); the median age was 12.86 years. More than half (59.4%) of sampled adolescents had received their booster dose on or after January 1, 2005; among those vaccinated in 2007, 89.1% received Tdap as their booster dose. Factors associated with nonreceipt of Td or Tdap included geographic location and not having a provider-reported well-child visit at ages 11 to 12 years. Almost three quarters of adolescents aged 13 to 17 years included in the NIS-Teen 2007 received a tetanus-containing vaccine, and almost one third received Tdap. Among adolescents who received a tetanus-containing vaccine in 2007, a total of 89.1% received the new Tdap vaccine in place of Td, as recommended. Adolescents not receiving Td or Tdap may face barriers to accessing health care. Research is needed to identify evidence-based strategies to improve vaccination coverage among adolescents.
    Article · Aug 2010
  • [Show abstract] [Hide abstract] ABSTRACT: Tdap is recommended for health care personnel (HCP) aged <65 years who received tetanus diphtheria or tetanus toxoid immunization (Td/TT) ≥2 years earlier. During a medical center Tdap vaccination campaign, we assessed the safety of use of a Td/TT to Tdap interval <2 years in HCP. We also describe reactogenicity in HCP who were aged ≥65 years or pregnant. HCP vaccinated with Tdap were surveyed to assess time since last Td/TT (≥2 years vs. <2 years), age, pregnancy status, and injection site adverse events (AEs) during the 2 weeks after Tdap. AE rates were calculated and compared by non-inferiority analysis using a predetermined margin of 10%. We searched clinic logbooks to assess for clinically important adverse events during the 2 months after Tdap. Of the 4524 vaccinated HCP, 2221 (49.1%) completed a safety survey which met criteria for analysis. Non-inferiority analysis found that rates of moderate and/or severe injection site AEs were not significantly greater in those vaccinated <2 years than in those vaccinated ≥2 years after previous Td/TT. Three serious adverse events were reported during the 2 months after vaccination, none in persons who were ≥65 years, pregnant or received Td/TT <2 years before. Our findings add to the body of evidence that a short interval between Td/TT and a single dose of Tdap is safe.
    Article · Sep 2010
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