Diphtheria, Tetanus, And Acellular Pertussis Research Articles

Routine vaccination coverage at ages 2 and 7, before, during, and after the COVID-19 pandemic: Results from the STARVAX surveillance system.

A decline in routine vaccination coverage in children has been observed after the onset of the COVID-19 pandemic, but it is unclear whether these declines were sustained over time. This analysis assessed changes in vaccination coverage at ages 2 and 7years for routinely administered vaccinations before, during, and after the COVID-19 pandemic. Vaccination coverage was measured using yearly data from the Standardized Reporting on Vaccination (STARVAX) surveillance system between December 31, 2019, and December 31, 2023. Four provinces (Alberta, Saskatchewan, Manitoba, and New Brunswick) and one territory (Yukon) produced reports from their immunization registries and provided the Public Health Agency of Canada with the numbers of vaccinated 2-year-old and 7-year-old children. Population estimates from Statistics Canada and the Yukon Bureau of Statistics were used as the denominators. There was a decline in vaccination coverage in 2023 compared to 2019. In 2-year-olds, coverage for one dose of the measles, mumps, and rubella (MMR) vaccine and four doses of the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine decreased from 89.5% to 82.5% and from 79.9% to 72.1%, respectively. Among 7-year-olds, DTaP (up-to-date) and MMR (two doses) vaccination coverage decreased from 77.1% to 68.8% and 86.3% to 75.6%, respectively. These declines are of concern and suggest that health care professionals should provide parents with accurate information regarding vaccines and encourage them to have their children vaccinated and keep vaccinations up to date.

Introduction of a hexavalent vaccine containing acellular pertussis into the national immunization program for infants in Peru: a cost-consequence analysis of vaccination coverage

BackgroundInfant vaccination coverage rates in Peru have declined in recent years, exacerbated by the COVID-19 pandemic. Introduction of the fully-liquid diphtheria, tetanus, and acellular pertussis (DTaP)-inactivated polio vaccine (IPV)-hepatitis B (HB)-Haemophilus influenzae type B (Hib) hexavalent vaccine (DTaP-IPV-HB-Hib) in Peru’s infant National Immunization Program may help improve coverage. We evaluated costs and healthcare outcomes, including coverage, of switching from a pentavalent vaccine containing whole-cell pertussis component (DTwP-HB-Hib) plus IPV/oral polio vaccine (IPV/OPV) to the hexavalent vaccine for the primary vaccination scheme (2, 4 and 6 months).MethodsThe analysis was performed over a 5-year period on a cohort of children born in Peru in 2020 (N = 494,595). Four scenarios were considered: the pentavalent plus IPV/OPV scheme (S1); replacing the pentavalent plus IPV/OPV scheme with the hexavalent scheme (S2); expanded delivery of the pentavalent plus IPV/OPV scheme (S3); expanded delivery of the hexavalent scheme (S4). Vaccine coverage and incidence of adverse reactions (ARs) were estimated using Monte Carlo simulations and previous estimates from the literature. Cases of vaccine-preventable diseases were estimated using a Markov model. Logistical and healthcare costs associated with these outcomes were estimated. Impact of key variables (including coverage rates, incidence of ARs and vaccine prices) on costs was evaluated in sensitivity analyses.ResultsThe overall cost from a public health payer perspective associated with the pentavalent plus IPV/OPV vaccine scheme (S1) was estimated at $56,719,350, increasing to $61,324,263 (+ 8.1%), $59,121,545 (+ 4.2%) and $64,872,734 (+ 14.4%) in scenarios S2, S3 and S4, respectively. Compared with the status quo (S1), coverage rates were estimated to increase by 3.1% points with expanded delivery alone, and by 9.4 and 14.3% points, if the hexavalent vaccine is deployed (S2 and S4, respectively). In both scenarios with the hexavalent vaccine (S2 and S4), pertussis cases would also be 5.7% and 8.7% lower, and AR rates would decrease by 32%. The cost per protected child would be reduced when the hexavalent vaccine scheme. Incidence of ARs was an important driver of cost variability in the sensitivity analysis.ConclusionsImplementation of the hexavalent vaccine in Peru’s National Immunization Program has a positive public health cost consequence.

Financial Burden as a Potential Barrier to Vaccine Completion in Post-hematopoietic Stem Cell Transplant Patients in Japan.

Introduction The administration of routine vaccinations to patients following hematopoietic stem cell transplantation (HSCT) is highly recommended. However, studies examining reasons for not completing vaccination in post-HSCT patients are lacking. Method We reviewed the medical records of patients who sought vaccination following HSCT from January 2012 to December 2018 at the Center for Infectious Diseases, Nara Medical University. Results Information regarding patients' backgrounds, administered vaccines, and reasons for not administering recommended vaccines was collected for the study. Thirty-five patients (22 men and 13 women) with a median time from HSCT to the first visit of 25 months were enrolled. Vaccine coverage was highest for diphtheria, tetanus, and acellular pertussis (DTaP) at 89% (31 patients), followed by 23-valent pneumococcal, measles/rubella/mumps, and Japanese encephalitis at 71% (25 patients), 71% (25 patients), and 63% (22 persons), respectively. However, vaccine coverage for hepatitis B, 13-valent pneumococcal, and Hib was low at 26% (three patients), 11% (four patients), and 40% (14 patients), respectively. The reason for not completing the recommended vaccination series was not provided for most cases; however, the economic barrier was cited for all vaccines. Discussion This study identified several cases in Japan where individuals stopped completing post-HSCT vaccinations due to financial constraints. Larger-scale studies may be necessary in Japan in the future for further investigation.

Lack of association between febrile seizures and vaccines containing diphtheria, tetanus, and acellular pertussis in Chinese children

ABSTRACT Background The association between the administration of vaccines containing diphtheria, tetanus, and acellular pertussis (DTaP) and febrile seizures (FSs) is unclear. This study aimed to evaluate the risk of FSs after the administration of DTaP-containing vaccines in Chinese children aged 1 to 23 months. Research design and methods A self-controlled case series (SCCS) design was adopted based on data from the Ningbo Regional Health Information Platform (NRHIP). The observation period was from 1 to 23 months of age. The relative incidences (RIs) within 0 to 3 days, 4 to 7 days, and 0 to 7 days after the administration of DTaP-containing vaccines were estimated. The remaining observation period was the control period. Results The RIs within 0 to 3 days, 4 to 7 days, and 0 to 7 days after any dose of DTaP-containing vaccines were 1.14 (95% CI 0.86 to 1.52), 0.89 (95% CI 0.65 to 1.23), and 1.02 (95% CI 0.82 to 1.26), respectively. Conclusions This study provides reassuring evidence that there is no increased risk of FSs immediately after the administration of DTaP-containing vaccines, which might serve to reassure both professionals and families with regard to the risk of FSs associated with DTaP-containing vaccines.

Development of a cell line-based in vitro assay for assessment of Diphtheria, Tetanus and acellular Pertussis (DTaP)-induced inflammasome activation

Safety and potency assessment for batch release testing of established vaccines still relies partly on animal tests. An important avenue to move to batch release without animal testing is the consistency approach. This approach is based on thorough characterization of the vaccine to identify critical quality attributes that inform the use of a comprehensive set of non-animal tests to release the vaccine, together with the principle that the quality of subsequent batches follows from their consistent production. Many vaccine antigens are by themselves not able to induce a protective immune response. The antigens are therefore administered together with adjuvant, most often by adsorption to aluminium salts. Adjuvant function is an important component of vaccine potency, and an important quality attribute of the final product. Aluminium adjuvants are capable of inducing NLRP3 inflammasome activation. The aim of this study was to develop and evaluate an in vitro assay for NLRP3 inflammasome activation by aluminium-adjuvanted vaccines. We evaluated the effects of Diphtheria-Tetanus-acellular Pertussis combination vaccines from two manufacturers and their respective adjuvants, aluminium phosphate (AP) and aluminium hydroxide (AH), in an in vitro assay for NLRP3 inflammasome activation. All vaccines and adjuvants tested showed a dose-dependent increase in IL-1β production and a concomitant decrease in cell viability, suggesting NLRP3 inflammasome activation. The results were analysed by benchmark dose modelling, showing a similar 50% effective dose (ED50) for the two vaccine batches and corresponding adjuvant of manufacturer A (AP), and a similar ED50 for the two vaccine batches and corresponding adjuvant of manufacturer B (AH). This suggests that NLRP3 inflammasome activation is determined by the adjuvant only. Repeated freeze-thaw cycles reduced the adjuvant biological activity of AH, but not AP. Inflammasome activation may be used to measure adjuvant biological activity as an important quality attribute for control or characterization of the adjuvant.

Does Missing or Delaying Doses of DTaP Vaccine Increase Pertussis Risk

Questions remain about children's level of protection when diphtheria, tetanus, and acellular pertussis (DTaP) vaccine doses are delayed or incomplete.

Effect of Preexisting Immunity to Tetanus Toxoid on the Efficacy of Tetanus Toxoid-Conjugated Heroin Vaccine in Mice

Opioid use disorder (OUD) is a serious health problem that has dramatically increased over the last decade. Although current therapies for the management of OUD can be effective, they have limitations. The complementary strategy to combat the opioid crisis is the development of a conjugate vaccine to generate high affinity antibodies in order to neutralize opioids in circulation before reaching the brain. The components of an opioid vaccine include an opioid hapten (6-AmHap) that is conjugated to a carrier protein (tetanus toxoid) with the addition of adjuvants (Army Liposome Formulation adsorbed to aluminum hydroxide-ALFA). There is no consensus in the literature as to whether preexisting immunity to the carrier protein may impact the immunogenicity of the conjugate vaccine by inducing an enhanced or suppressed immune response to the hapten. Here, we investigated whether pre-exposure to tetanus toxoid would affect the immunogenicity and efficacy of the heroin vaccine, TT-6-AmHap. Mice were primed with diphtheria, tetanus, and acellular pertussis (DTaP) vaccine at weeks -4 and -2, then immunized with TT-6-AmHap vaccine at weeks 0, 3, and 6. Using ELISA and behavioral assays, we found that preexisting immunity to tetanus toxoid had no influence on the immunogenicity and efficacy of the TT-6-AmHap vaccine.

Risk factors for pertussis among children hospitalized for pertussis during 2016–2017, in Guizhou Province of China: a case-control study

AimPertussis is a respiratory tract infection, the vaccine for which was introduced in the Expanded Programme on Immunization (EPI) in Guizhou Province of China (hereafter referred as Guizhou) in the 1980s. This vaccine rapidly decreased incidence rates of pertussis in the province, however, despite the wide high coverage of the diphtheria, tetanus and acellular pertussis (DTaP) combined vaccine, there has been a resurgence of pertussis since 2014. Even with this recent increase in disease transmission, risk factors for pertussis infection have not been evaluated in Guizhou. We aimed to provide information on pertussis risk factors and insight on designing targeted pertussis control policies and measures through this study. MethodsA 1∶2 matched retrospective case-control study was conducted between 2016 and 2017, involving infants and children younger than 6 years old and parents of the participants. The enrolled cases included clinical and laboratory confirmed pertussis cases according to the WHO-recommended pertussis definition. Controls were selected from children in the same neighborhood who were not diagnosed with pertussis prior to our investigation and did not exhibit any clinical manifestations of pertussis. ResultsThe household size [Matched odds ratio (ORm) = 1.4, 95% confidence interval (CI): 1.1–1.7] and household members with antecedent cough (ORm = 3.6, 95% CI: 1.8–7.2) were significantly associated with their child’s pertussis onset. The parents’ occupations were significantly associated with their child’s pertussis onset (ORm = 9.4, 95% CI: 1.6–54.8, for mother side; ORm = 4.5, 95% CI: 1.2–16.5, for father side), when they worked in the business and/or service industry. Having family members with a history of cough was an independent risk factor for pertussis [Adjusted odds ratio (AOR) = 43.6, 95% CI: 2.7–694.0]. Besides, the parents' demographic characteristics and DTaP doses were not found to be independent factors. ConclusionHousehold exposure is an important risk factor for pertussis infection in infants and young children and should therefore be considered as a major factor during formulation of pertussis control policies and measures.

Variability of in vivo potency tests of Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccines

For batch release of legacy vaccines such as DTaP, in vivo potency release assays are required. We quantified the variability of in vivo potency release assays for four DTaP (Diphtheria, Tetanus, acellular Pertussis) products of different manufacturers. With their large CV (Coefficients of Variance) ranging from 16% to 132%, these in vivo assays are of limited value to ensure their potency is consistent and similar to the clinical batches used for the marketing authorisation. Our data show that, although individual potency test results show high variability, the DTaP batches are manufactured with great consistency, because repeated potency testing yields similar averages for the different batches. The economic impact of variability of in vivo tests is significant since it may result in the need for greater amount of antigen than may be required or for repeating a test.For monitoring the consistency of potency, in vitro assays are superior to in vivo assays. Animal-free potency determination is common practice for newly developed vaccines under modern GMP quality systems. However, replacement of in vivo potency tests for legacy vaccines like DTaP is challenging and would require a ‘reverse characterisation’ strategy in which the antigens are further characterised at the level of drug substance and drug product to identify critical quality attributes (CQA) that can be tested with in vitro assays. Based on these an updated set of release tests without animal tests can be proposed. Our data can serve as benchmark for the innovative methods.

Evaluation of the safety of diphtheria, tetanus and acellular pertussis containing combination vaccines in Chengdu, 2015-2019

Objective: To evaluate the safety of diphtheria, tetanus and acellular pertussis (DTaP) containing combination vaccines used in Chengdu. Methods: The AEFI reports data of DTaP vaccine, DTaP-Haemophilus influenza type b combined vaccine (DTaP-Hib) and DTaP-inactivated poliovirus-Hib combined vaccine (DTaP-IPV-Hib) in Chengdu from 2015 to 2019 were collected through the national immunization management system. Description epidemiological method was used to analyze the data. Results: From 2015 to 2019, a total of 8 234 cases of AEFI of DTaP containing combination vaccines were reported in Chengdu, with a reported incidence of 194.55/100 000 doses, including 7 897 cases of common adverse reaction (168.59 per 100 000) and 234 cases of rare adverse reaction (5.53 per 100 000). The DTaP vaccine reported 4 240 cases AEFI (140.63 per 100 000), the DTaP-Hib vaccine reported 2 490 cases AEFI (399.09 per 100 000) and the DTaP-IPV-Hib vaccine reported 1 504 cases AEFI (253.49 per 100 000). All the three vaccines had the highest incidence for the booster doses; the rare adverse reaction were mainly Anaphylactic Reaction (6.27 per 100 000). Conclusions: The AEFI monitor system had high sensitivity, and the rare adverse reaction rate was extremely low, all the vaccines had good safety profiles. The Thrombocytopenic purpura and Laryngeal Edema should be paid more attention to.

The Resurgence of Measles, Mumps, and Pertussis

Although vaccines are one of the greatest scientific innovations to prevent disease and promote well-being, 1 in 10 children is not being vaccinated. This has directly contributed to the rise in vaccine-preventable diseases. Because of the high contagiousness of measles, mumps, and pertussis, innovative efforts are paramount to prevent disease outbreaks in the United States and worldwide. This article reviews measles, mumps, and pertussis; explains the resurgence of these vaccine-preventable diseases; and offers evidence-based solutions for increasing vaccination rates.

Age-appropriate compliance and completion of up to five doses of pertussis vaccine in US children

ABSTRACTBackground: In the United States (US), diphtheria, tetanus, and acellular pertussis (DTaP) vaccination is recommended at 2, 4, and 6 months (doses 1–3), 15–18 months (dose 4), and 4–6 years (dose 5). The objective of this study (GSK study identifier: HO-14–14383) was to examine DTaP completion and compliance rates among commercially insured and Medicaid-enrolled children. Secondarily, the study aimed at identifying predictors of compliance/completion.Methods: Truven Health MarketScan Commercial and Multi-State Medicaid databases (2005–2013) were analyzed separately. Children born during 2005–2011 with ≥ 2 years continuous enrollment from birth provided data for doses 1–4; those with continuous enrollment from birth to their seventh birthday provided dose 5 data. Series compliance (each recommended dose by 3, 5, and 7 months; 19 months; seventh birthday) and completion (3 doses by 8 months; 4 by 24 months; 5 by seventh birthday) were calculated. Predictors of compliance/completion were identified using multivariable logistic regression.Results: A total of 367,493 commercially insured and 766,153 Medicaid-enrolled children were followed for ≥ 2 years; and 23,574 and 41,284, respectively, for ≥ 7 years. Series compliance to doses 1–3, 1–4, and 1–5 were 67.2%, 55.3%, 47.5% (commercial) and 37.4%, 27.3%, 14.4% (Medicaid), respectively. Predictors of better compliance/completion included: later birth year (commercial/Medicaid) and higher household income (commercial); predictors of worse compliance/completion included: Northeast residence (commercial), birth hospitalization ≥ 14 days (commercial/Medicaid), and Black race/ethnicity (Medicaid).Conclusions: DTaP series compliance/completion improved over time, but appear to be suboptimal. As this could increase pertussis risk, greater awareness of the importance of timely vaccination completion is needed.GSK study identifier: HO-14–14383

Safer Pertussis Vaccines for Children: Trading Efficacy for Safety.

* Abbreviations: DTaP — : diphtheria, tetanus, and acellular pertussis DTwP — : diphtheria, tetanus, whole-cell pertussis VAERS — : Vaccine Adverse Event Reporting System The decision to replace effective whole-cell vaccines for pertussis with less reactogenic but potentially less efficacious acellular vaccines for the primary immunization of children in the United States in the 1990s was carefully considered.1 The performance of the heat- or formalin-inactivated Bordetella pertussis whole-cell vaccine combined with diphtheria and tetanus toxoids (diphtheria, tetanus, whole-cell pertussis [DTwP]) licensed in the 1940s had resulted in a dramatic decrease in the number of cases of pertussis to a nadir in the mid-1970s.2 However, parallel to this success, the occurrence of rare but potentially serious adverse events associated with DTwP administration became unacceptable. Particularly concerning was the occurrence of high fever, febrile seizures, prolonged crying, and acute encephalopathy that sometimes followed whole-cell pertussis vaccination in some young infants. The development and licensure of diphtheria, tetanus, and acellular pertussis (DTaP) vaccines in the United States in the 1990s was an anticipated event for pediatric providers and parents who feared the reactogenicity associated with the administration of DTwP vaccines in infants and toddlers. … Address correspondence to Flor M. Munoz, MD, Department of Pediatrics, Section of Infectious Diseases, Baylor College of Medicine, Texas Children’s Hospital, Feigin Tower, 1102 Bates, Houston, TX 77030. E-mail: florm{at}bcm.edu

Diphtheria, Tetanus, and Acellular Pertussis Vaccine Is Safe

The current pertussis vaccine for children aged 2 months to 7 years, diphtheria, tetanus, and acellular pertussis (DTaP), was introduced in the 1990s

Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine

BackgroundThe effectiveness of diphtheria, tetanus, and acellular pertussis (DTaP) vaccines wanes substantially after the 5th dose given at ages 4–6years, but has not been described following 5 doses of the same type of DTaP vaccine. We investigated waning effectiveness against pertussis in California over nearly 10years, which included large pertussis outbreaks, following 5 doses of GSK DTaP vaccines (DTaP3). MethodsWe conducted a case-control study (NCT02447978) of children who received 5 doses of DTaP at Kaiser Permanente Northern California from 01/2006 through 03/2015. We compared time since the 5th dose in confirmed pertussis polymerase chain reaction (PCR)-positive cases with pertussis PCR-negative controls. We used logistic regression adjusted for calendar time, age, sex, race, and service area to estimate the effect of time since the 5th DTaP dose on the odds of pertussis. Our primary analysis evaluated waning after 5 doses of DTaP3. We also examined waning after 5 doses of any type of DTaP vaccines. ResultsOur primary analysis compared 340 pertussis cases diagnosed at ages 4–12years with 3841 controls. The any DTaP analysis compared 462 pertussis cases with 5649 controls. The majority of all DTaP doses in the study population were DTaP3 (86.8%). Children who were more remote from their 5th dose were less protected than were children whose 5th dose was more recent; the adjusted odds of pertussis increased by 1.27 per year (95% CI 1.10, 1.46) after 5 doses of DTaP3 and by 1.30 per year (95% CI 1.15, 1.46) after any 5 DTaP vaccines doses. ConclusionsWaning protection after DTaP3 was similar to that following 5 doses of any type of DTaP vaccines. This finding is not unexpected as most of the DTaP vaccines administered were DTaP3. Following 5 doses of DTaP3 vaccines, protection from pertussis waned 27% per year on average.NCT number: NCT02447978.

Effectiveness of Vaccination During Pregnancy to Prevent Infant Pertussis.

Vaccination against pertussis during pregnancy is recommended to protect newborns, yet there is limited information about the effectiveness of maternal tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine before the first infant dose of diphtheria, tetanus and acellular pertussis (DTaP) vaccine and during the first year of life in infants who have received DTaP. In a retrospective cohort study of infants born at Kaiser Permanente Northern California from 2010 to 2015, we estimated the effectiveness of maternal pertussis vaccination for protecting newborns against pertussis in the first 2 months of life and in the first year of life accounting for each infant DTaP dose. Among 148 981 newborns, the vaccine effectiveness of maternal Tdap was 91.4% (95% confidence interval [CI], 19.5 to 99.1) during the first 2 months of life and 69.0% (95% CI, 43.6 to 82.9) during the entire first year of life. The vaccine effectiveness was 87.9% (95% CI, 41.4 to 97.5) before infants had any DTaP vaccine doses, 81.4% (95% CI, 42.5 to 94.0) between doses 1 and 2, 6.4% (95% CI, -165.1 to 66.9) between doses 2 and 3, and 65.9% (95% CI, 4.5 to 87.8) after infants had 3 DTaP doses. Maternal Tdap vaccination was highly protective against infant pertussis, especially in the first 2 months of life. Even after infant DTaP dosing, there was evidence of additional protection from maternal Tdap vaccination for the first year of life. This study strongly supports the United States' current recommendation to administer Tdap during each pregnancy.

Uptake of rotavirus vaccine among US infants at Immunization Information System Sentinel Sites

ObjectiveCoverage with rotavirus vaccine among US children has been lower compared to that with other routine childhood vaccines. Our objectives were to examine rotavirus vaccine (RV) uptake over time compared to other routine vaccinations, ages at administration, and quantitate potential missed opportunities for RV receipt. MethodsWe analyzed data from 6 Immunization Information System (IIS) Sentinel Sites, which represent approximately 10% of the United States (US) pediatric population. Among infants aged 5months, we compared uptake of ⩾1 dose of RV, to that of Diphtheria, Tetanus, and acellular Pertussis (DTaP) and pneumococcal conjugate vaccine (PCV), for each quarter during 2006–2013. We used data from infants in the 2012 birth cohort to examine RV receipt in more detail. ResultsAmong infants aged 5months, the average site coverage with ⩾1 dose of RV reached 78% in 2010 and subsequently stayed steady at 79–81% through 2013. The average difference between ⩾1 dose DTaP coverage and RV coverage remained between about 6 and 8 percentage points during mid-2012 through 2013. Infants born in 2012 received RV doses closely in line with the timing recommended by the ACIP. Approximately one-third of the difference in coverage between ⩾1 dose of DTaP and ⩾1 dose of RV among infants could be due to the maximum age restriction of the first RV dose. The other two-thirds of the difference appears to have been a result of potential missed opportunities for starting the RV series--these infants received another routine immunization when age eligible to receive RV dose 1, but did not receive RV. ConclusionUptake with RV during infancy remains below that of other routine vaccines. Understanding the barriers to administration of RV among age-eligible infants could help improve vaccine coverage.

Kaiser Permanente Northern California pregnancy database: Description and proof of concept study

Background/objectiveWe 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. MethodsAll Kaiser Permanente Northern California (KPNC) live births and their mothers were eligible for inclusion in the pregnancy database. We used the medical record number (MRN), a unique identifier, to retrieve information about events that occurred during the pregnancy and at delivery and linked this same MRN to newborns for post-partum follow up. We conducted a retrospective cohort study to evaluate the association between receipt of tetanus, diphtheria and acellular pertussis (Tdap) vaccine during pregnancy and fever 0–3days after the first dose of diphtheria tetanus and acellular pertussis (DTaP) vaccine in the infant. The study included infants who were born at ⩾37weeks gestation from January 1, 2009 – October 1, 2015 and who received their first DTaP vaccine between 6 and 10weeks of age. We utilized diagnostic codes from inpatient, emergency department, outpatient clinics, and telephone calls. We identified fever using ICD 9 code 780.6, recorded temperature ⩾101 degree Fahrenheit, or parental report. ResultsThe database contained the starting and ending date of each pregnancy and basic demographic characteristics of mothers and infants. There were 859,699 women and 873,753 children in the database as of January 2016.The proof of concept study included 148,699 infants. In a multivariable logistic regression analysis, Tdap vaccination during pregnancy was not associated with infant fever 0–3daysafter first dose of DTaP (adjusted odds ratio=0.92, 95% CI 0.82–1.04). ConclusionThe KPNC pregnancy database can be used for studies investigating exposure during pregnancy and outcomes in mothers and/or infants, particularly monitoring vaccine safety and effectiveness.

What are the preferences of health care professionals in Germany regarding fully liquid, ready-to-use hexavalent pediatric vaccine versus hexavalent pediatric vaccine that needs reconstitution?

Diphtheria, tetanus and acellular pertussis (DTaP) based combined vaccines have led to significant reduction in incidence of several serious pediatric infectious diseases. A new, fully liquid combined hexavalent vaccine has been introduced and has been shown to reduce administration time. This fully liquid vaccine may also be simpler to administer and could reduce handling errors. The present study was designed to understand the value that health care providers (HCPs) place on aspects of injection devices for combined hexavalent vaccine programs in Germany. A discrete choice experiment (DCE) was designed to elicit the views of HCPs regarding hexavalent vaccines. The key attributes of injection devices were identified through a focused literature search and interviews with HCPs. Five key attributes, each with two or three levels were described which included: type of device, experience of this hexavalent vaccine on the German market, preparation time, probability of handling errors, and dosage errors. Physicians (n=150) and nurses (n=150) who administered hexavalent vaccines in Germany completed the survey. Choice data were analyzed using the conditional logit procedure. All attributes were significant and important independent influences on physicians’ and nurses’ choices. Reducing any “probability of dosage errors” was the most important attribute. Both physicians and nurses had a strong preference to reduce preparation time. All other things equal both groups also significantly preferred a fully liquid hexavalent vaccine. They also preferred vaccines that had been on the market for a few years compared to ones that had not (especially the physicians). Additional analyses explored participants’ preferences in more detail through interaction terms. The DCE choice data provide useful insights into how HCPs view each aspect of the vaccination device. Overall, the HCPs preferred fully liquid vaccines. The survey also highlighted the importance of handling and dosage errors, reducing preparation time, and also experience of the HCPs with the use of a vaccine. The survey work included physicians and nurses and explored their views separately.

Evidence of herd immunity and sustained impact of rotavirus vaccination on the reduction of rotavirus-related medical encounters among infants from 2006 through 2011 in the United States.

Rotavirus (RV) is the leading cause of severe acute gastroenteritis among young children. Since the US licensure of the pentavalent RV vaccine (RV5) and the monovalent RV vaccine (RV1), a decline of RV activity has been observed. To describe patterns of RV-related health care utilization among infants receiving RV vaccines (RVVs). A large national health insurance claims database was used to identify infants born from January 2002 through July 2011. From this cohort, infants were divided into three groups: (1) those who received a RVV, (2) those receiving a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine before the introduction of RVV (February 2006), and (3) those receiving DTaP without a concurrent RVV during the period of RVV availability. Study outcomes were rotavirus gastroenteritis (RGE) and acute gastroenteritis. Longitudinal, seasonal RGE incidence patterns among the RVV cohort (n = 140,952) were compared with the referent DTaP-vaccine cohort (n = 131,529). More than 91% of administered RVV were RV5. Mean peak incidence of RV medical encounters in RV-vaccinated infants was 95-96% lower than among DTaP-vaccinated infants who did not receive RVV. RGE incidence among the non-RV-vaccinated DTaP recipients in the RVV-available period (110 per 100,000 infants) was lower than among DTaP recipients in the pre-RVV period (151 per 100,000 infants). The highest RGE incidence in the 2007-2011 period was among older non-RV-vaccinated infants. Analysis of a national medical claims database indicates a sustained and substantial decrease in the seasonal RV medical claims pattern after the introduction of RVV. This analysis also reveals evidence of herd immunity, although unvaccinated infants continue to be at risk and contribute to smaller seasonal peaks in RV disease activity.