A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response.

Background: Immunization of pregnant women with tetanus-diphtheria-acellular pertussis vaccine (Tdap) provides protection against pertussis to the newborn infant. Methods: In a randomized, controlled, observer-blind, multicenter clinical trial, we measured the safety and immunogenicity of Tdap during pregnancy and the effect on the infant's immune response to primary vaccination at 2, 4, and 6 months and booster vaccination at 12 months of age. A total of 273 women received either Tdap or tetanus-diphtheria (Td) vaccine in the third trimester and provided information for the safety analysis and samples for the immunogenicity analyses; 261 infants provided serum for the immunogenicity analyses. Results: Rates of adverse events were similar in both groups. Infants of Tdap recipients had cord blood levels that were 21% higher than maternal levels for pertussis toxoid (PT), 13% higher for filamentous hemagglutinin (FHA), 4% higher for pertactin (PRN), and 7% higher for fimbriae (FIM). These infants had significantly higher PT antibody levels at birth and at 2 months and significantly higher FHA, PRN, and FIM antibodies at birth and 2 and 4 months, but significantly lower PT and FHA antibody levels at 6 and 7 months and significantly lower PRN and FIM antibody levels at 7 months than infants whose mothers received Td. Differences persisted prebooster at 12 months for all antigens and postbooster 1 month later for PT, FHA, and FIM. Conclusions: This study demonstrated that Tdap during pregnancy results in higher levels of antibodies early in infancy but lower levels after the primary vaccine series. Clinical Trials Registration: NCT00553228.

Implementation of a universal rotavirus vaccination program: comparison of two delivery systems.

BACKGROUND: Rotavirus vaccine is recommended for all infants in Canada. To evaluate the logistics of implementing a universal rotavirus vaccination program, we compared the effectiveness of program implementation in jurisdictions with either a physician-administered or public health nurse-administered program. METHODS: All infants born between October 1, 2010 and September 30, 2012 in Prince Edward Island and Nova Scotia's Capital District Health Authority were eligible for the vaccination program. A universal rotavirus vaccination program was implemented and delivered in public health clinics in Prince Edward Island and in physicians' offices in Nova Scotia. RESULTS: Engagement of vaccinators in delivery of the universal vaccination program was more successful in Prince Edward Island than in Nova Scotia. Vaccine coverage rates rose rapidly in Prince Edward Island, exceeding 90% for both doses within 3 months and remaining at those levels over the two-year program. In contrast, coverage rates in Nova Scotia rose more slowly and never exceeded 40% during the two years. Access to coverage data was more timely and accurate in Prince Edward Island than Nova Scotia. CONCLUSION: A universal rotavirus vaccination program delivered through public health clinics achieved more rapid and higher levels of coverage than a program administered through physicians' offices. TRIAL REGISTRATION: NCT01273077.

Impact of a parent-directed pamphlet about pain management during infant vaccinations on maternal knowledge and behavior.

PURPOSE: To evaluate the impact of a parent-directed instructional pamphlet about managing pain during infant vaccinations. DESIGN AND SAMPLE: New mothers hospitalized following birth of an infant at two hospitals participated in a "before-and-after" study. In the "after" phase, the pamphlet was passively inserted in discharge packages at the intervention hospital. MAIN OUTCOMES: Maternal knowledge and self-reported use of pain-management interventions during routine infant two-month vaccinations. RESULTS: Altogether, 354 mothers participated. A two-way (site, phase) ANOVA revealed no interaction (site 3 phase) in knowledge or use of pain-management strategies after routine two-month infant vaccinations; hence, there was no evidence of a benefit provided by the pamphlet. However, within the intervention site, only 21 percent of mothers read the pamphlet. Reading the pamphlet was associated with higher knowledge. This suggests some possible benefits of the pamphlet, provided that mothers read it.

Who knows more about immunization?: Survey of public health nurses and physicians.

OBJECTIVE: To report the findings of a knowledge survey of nurse and physician immunization providers. DESIGN: Cross-sectional postal survey assessing demographic characteristics and vaccine knowledge. SETTING: British Columbia (BC). PARTICIPANTS: Nurse and physician immunization providers in BC. MAIN OUTCOME MEASURES: Knowledge of vaccine-preventable diseases, vaccines in general, and vaccine administration and handling practices. RESULTS: Survey responses were received from 256 nurses and 292 physicians (response rates of 48.6% and 18.3%, respectively). Most nurses (98.4%) reported receiving immunization training outside of the academic setting compared with 55.6% of physicians. Overall, nurse immunizers scored significantly higher than physician immunizers on all 3 domains of immunization knowledge (83.7% vs 72.8%, respectively; P < .001). Physicians scored highest on the vaccine-preventable disease domain and least well on the general vaccine domain. Nurses with more experience as health care providers scored higher. Physicians scored higher if they were female, served patient populations predominantly younger than 5 years, or received immunization training outside of academic settings. CONCLUSION: In BC, nurse immunizers appear to have higher overall immunization knowledge than physicians and are more likely to receive immunization training when in practice. Physician immunizers might benefit most from further training on vaccines and vaccine administration and handling.

Influenza immunization practices and policies for health care students in Canada.

BACKGROUND: Influenza vaccine is recommended for all health care providers including health care students. Little is known about how health care student programs provide information about influenza vaccination to their students, deliver vaccines and document their vaccination status. METHODS: A mixed-methods approach was used and included key informant interviews of program coordinators for health care student programs in Halifax (Nova Scotia) and a national survey of program coordinators of health care student programs across Canada. RESULTS: All 21 coordinators of programs that had students placed at the IWK Health Centre (Halifax, Nova Scotia) during the influenza season were interviewed. Surveys were completed by 93 (36.3%) of 256 eligible coordinators representing 134 different programs (response rate 52.3%). Most programs encouraged seasonal influenza vaccination but only 28 (20.9%) required it. None of the Halifax programs delivered influenza vaccine and most preferred a coordinated, centrally administered program. In contrast, many programs across Canada delivered influenza vaccine and did not desire a centralized process. CONCLUSION: There is considerable variability in the delivery of influenza vaccine to health care students across Canada. Coordinated programs may be desirable where delivery programs do not already exist.

HISTORIQUE: L'administration du vaccin contre l'influenza est recommandée pour tous les dispensateurs de soins, y compris les étudiants du domaine de la santé. On ne sait pas grand-chose de la manière dont les programmes informent leurs étudiants du milieu de la santé du vaccin contre l'influenza, dont ils prévoient l'administration du vaccin et dont ils vérifient leur statut vaccinal. MÉTHODOLOGIE: Les chercheurs ont privilégié une méthode mixte qui incluait des entrevues auprès d'informateurs clés, soit les coordonnateurs des étudiants des programmes du domaine de la santé de Halifax (Nouvelle-Écosse), et une étude nationale des coordonnateurs des étudiants des programmes du domaine de la santé du Canada. RÉSULTATS: Les 21 coordonnateurs qui avaient des étudiants en stage à l'IWK Health Centre de Halifax, en Nouvelle-Écosse, pendant la saison d'influenza, ont participé à une entrevue. De plus, 93 (36,3 %) des 256 coordonnateurs admissibles ont rempli le sondage, représentant 134 programmes différents (taux de réponse de 52,3 %). La plupart des programmes favorisaient l'administration du vaccin contre l'influenza saisonnière, mais seulement 28 (20,9 %) l'exigeaient. Aucun programme de Halifax n'assurait l'administration du vaccin contre l'influenza, et la plupart auraient préféré un programme d'administration coordonné et centralisé. Par contre, de nombreux programmes au Canada administrent le vaccin contre l'influenza et ne souhaitent pas de processus centralisé. CONCLUSION: On constate une nette variabilité dans l'administration du vaccin contre l'influenza aux étudiants du domaine de la santé du Canada. Des programmes coordonnés pourraient être souhaitables aux endroits où il n'y a pas encore de services.

Effect of respiratory hospitalization during pregnancy on infant outcomes.

The purpose of this study was to determine whether maternal hospitalization for a respiratory-related condition during influenza season results in an increased risk of neonatal morbidity. With the use of a 13-year population-based cohort study of all singleton live births in Nova Scotia (1990-2002), neonatal outcomes were compared between women with and without hospital admission for respiratory illness during influenza season at any time in pregnancy. Logistic regression analyses were performed to examine infant outcomes and to estimate relative risks and 95% confidence intervals. Infants who were born to mothers who had been hospitalized for respiratory illness during influenza season at any time during pregnancy were more likely to be small for gestational age (15.3% vs 9.7%; adjusted relative risk, 1.66; 95% confidence interval, 1.11-2.49) and to have lower mean birthweight (3348.5 ± 498.2 g vs 3531.3 ± 504.1 g; ß score, -86.67; P < .009) than were infants who were born to women without an influenza-season respiratory hospitalization during pregnancy. Our findings in a cohort of singleton infants who were born in a high-resource setting support the findings that were described in Bangladesh that demonstrated an increased number of small-for-gestational-age infants and a lower mean birthweight among babies who were born to mothers who were not protected by influenza vaccine.

Identifying attitudes, beliefs and reported practices of nurses and doctors as immunization providers.

AIM: This paper is a report of a study conducted to examine the attitudes, beliefs, behavioural intentions and self-reported behaviour of nurses and physicians relating to key immunization behaviours and compare the findings for nurses and physicians. BACKGROUND: Immunization is an important and effective public health intervention. Understanding immunization providers' attitudes and beliefs toward immunization has the potential to improve educational efforts and lead to behavioural change. METHOD: A postal survey was conducted with all immunization providers in British Columbia, Canada, in 2005. The survey elicited data on demographics, practice characteristics, attitudes, perceived social norms and perceived behavioural control related to key immunization behaviours. RESULTS: Responses were received from 344 nurses and 349 physicians. The response rate was 67% for nurses and 22% for physicians. More nurses than physicians thought that administering all recommended vaccines at one visit was important (89.2% vs. 63.2%P < 0.001); nurses felt more pressure from parents to administer all recommended vaccines (82.4% vs. 48.7%P < 0.001), and nurses were also more likely to intend to give all recommended vaccines at one visit (98.8% vs. 73.8%P < 0.001). Both nurses and physicians thought that their own receipt of influenza vaccine each year was important (88.9%, 87.1% respectively P = 0.65). CONCLUSION: The foundational work done to develop the survey tool can be used to modify it so that survey findings can be validated according to the Theory of Planned Behaviour. The results could inform the development of behavioural change interventions targeting the identified determinants of immunization provider behaviour.

THE VAXED PROJECT: an assessment of immunization education in Canadian health professional programs.

BACKGROUND: Knowledge & attitudes of healthcare providers (HCP) have significant impact on frequency with which vaccines are offered & accepted but many HCP are ill equipped to make informed recommendations about vaccine merits & risks. We performed an assessment of the educational needs of trainees regarding immunization and used the information thus ascertained to develop multi-faceted, evaluable, educational tools which can be integrated into formal education curricula. METHODS: (i) A questionnaire was sent to all Canadian nursing, medical & pharmacy schools to assess immunization-related curriculum content (ii) A 77-item web-based, validated questionnaire was emailed to final-year students in medicine, nursing, & pharmacy at two universities in Nova Scotia, Canada to assess knowledge, attitudes, & behaviors reflecting current immunization curriculum. RESULTS: The curriculum review yielded responses from 18%, 48%, & 56% of medical, nursing, & pharmacy schools, respectively. Time spent on immunization content varied substantially between & within disciplines from <1 to >50 hrs. Most schools reported some content regarding vaccine preventable diseases, immunization practice & clinical skills but there was considerable variability and fewer schools had learning objectives or formal evaluation in these areas. 74% of respondents didn't feel comfortable discussing vaccine side effects with parents/patients & only 21% felt they received adequate teaching regarding immunization during training. CONCLUSIONS: Important gaps were identified in the knowledge of graduating nursing, medical, & pharmacy trainees regarding vaccine indications/contraindications, adverse events & safety. The national curriculum review revealed wide variability in immunization curriculum content & evaluation. There is clearly a need for educators to assess current curricula and adapt existing educational resources such as the Immunization Competencies for Health Professionals in Canada.

Cervical cancer prevention by vaccination: nurses' knowledge, attitudes and intentions.

AIM: This paper is a report of a survey: (1) to document nurses' knowledge, attitudes and information needs regarding human papillomavirus prevention and (2) to determine factors associated with their willingness to recommend human papillomavirus vaccines. BACKGROUND: Persistent infection with human papillomavirus has been causally linked to cervical cancer. Two human papillomavirus vaccines have recently been approved for use in more than 65 countries. Nurses' level of support for the prevention of human papillomavirus related diseases by vaccination has not been researched. METHODS: A survey was conducted in 2007. Self-administered questionnaires were mailed to 1799 randomly selected nurses. Descriptive statistics were generated for all variables. Multivariable logistic regression models were estimated to determine variables associated with the willingness to recommend human papillomavirus vaccines. RESULTS: A total of 946 questionnaires were analyzed and showed that: 97% of nurses perceived routinely recommended vaccines as very useful; 93% would support human papillomavirus vaccination if it is publicly funded; 85% would recommend human papillomavirus vaccines to their patients; 33%, 46% and 61% expect the vaccination to permit screening to begin later in life, reduction of the frequency of screening, and reduction of the number of postscreening interventions, respectively. Respondents' knowledge score was 3.8 out of 7. Several modifiable factors, including knowledge, perceived self-efficacy, and societal and colleagues support were associated with willingness to recommend vaccines. CONCLUSION: Most nurses' support human papillomavirus vaccination, but their active involvement should not be taken for granted. Targeted educational efforts are needed to ensure nurses' involvement in the prevention of human papillomavirus-related diseases.

Influenza vaccine programs and pregnancy: new Canadian evidence for immunization.

Among healthy pregnant women, excess deaths due to influenza were documented during pandemics, but the impact of influenza on pregnant women in non-pandemic years is not clear. In Canada, influenza immunization is recommended for pregnant women only if they have comorbidities known to place them at increased risk of complications or if they deliver during influenza season, therefore becoming a contact of a high-risk infant. The National Advisory Committee on Immunization has indicated that additional evidence, relevant to healthy pregnant Canadian women, is needed to support a recommendation for influenza immunization for all pregnant women. In this commentary we summarize new Canadian data supporting universal influenza immunization for pregnant women and discuss ways in which the Society of Obstetricians and Gynaecologists of Canada might take a leadership role in making influenza vaccination in pregnancy a priority to decrease influenza morbidity in pregnant Canadian women.

When is it permissible to dismiss a family who refuses vaccines? Legal, ethical and public health perspectives.

Although immunization is one of the most important health interventions of the 20th century, cases of infectious disease continue to occur. There are parents who refuse immunization for their children, creating a dilemma for the primary care physician who must consider the best interest of the individual child as well as that of the community. Some physicians, when faced with parents who refuse immunization on behalf of their children, choose to dismiss these families from their practice. Given the existing shortage of primary care physicians across Canada, this decision to dismiss families based on vaccine refusal has far-reaching implications. The present article explores this issue in the Canadian context from a legal, ethical and public health perspective.

Prenatal Screening for HIV in Nova Scotia: Survey of Postpartum Women and Audit of Current Prenatal Screening Practices.

BACKGROUND: Current guidelines for screening for HIV infections in Nova Scotia recommend an opt-in approach in which patients are counselled and consent to testing. The objectives of the present study were to measure adherence to these recommendations, to explore women's knowledge, attitudes, beliefs and behaviours concerning HIV screening, and to compare these results with prenatal screening practices for rubella, hepatitis B and group B streptococcus. METHODS: All women who gave birth consecutively during a seven-week period were recruited. Study participants were interviewed to determine their knowledge, attitudes and beliefs concerning prenatal screening. Hospital and laboratory records were reviewed for information concerning prenatal screening and perinatal treatment to audit screening practices. RESULTS: A total of 279 patients were enrolled in the study, representing 58% of those eligible. The HIV screening rate was 72%, compared with 95% for rubella, 89% for hepatitis B and 24% for group B streptococcus. Of the participants tested for HIV, 80% were aware of being tested. Of all the study participants, 17% indicated having received pretest counselling about HIV, 56% volunteered to be tested for HIV, 78% received the test results, and 3.8% received post-test counselling. More participants preferred an opt-out approach to HIV screening (50%), where testing is routinely performed on everyone, rather than the opt-in approach (43%). Participants displayed a similar preference for screening for the other infections. INTERPRETATION: HIV prenatal testing rates in Nova Scotia are comparable with those of other provinces that recommend an opt-in approach, but are lower than testing rates for opt-out programs. Most study participants were not screened using the recommended opt-in approach.

Knowledge, attitudes, beliefs, and behaviors of parents and healthcare providers before and after implementation of a universal rotavirus vaccination program.

OBJECTIVE: In Canada, rotavirus vaccine is recommended for all infants, but not all provinces/territories have publicly funded programs. We compared public and healthcare provider (HCP) knowledge, attitudes, beliefs, and behaviors in a province with a public health nurse-delivered, publicly funded rotavirus vaccination program to a province with a publicly funded, physician-delivered program. A third province with no vaccination program acted as a control. DESIGN: Information about knowledge, attitudes, beliefs, and behaviors of parents whose children were eligible for the universal program and healthcare providers responsible for administering the vaccine were collected through the use of two validated surveys distributed in public health clinics, physicians' offices, and via e-mail. Early and postvaccine-program survey results were compared. RESULTS: A total of 722 early implementation and 709 postimplementation parent surveys and 180 early and 141 postimplementation HCP surveys were analyzed. HCP and public attitudes toward rotavirus vaccination were generally positive and didn't change over time. More parents postprogram were aware of the NACI recommendation and the vaccination program and reported that their healthcare provider discussed rotavirus infection and vaccine with them. Prior to the program across all sites, more physicians than nurses were aware of the national recommendation regarding rotavirus vaccine. In the postprogram survey, however, more nurses were aware of the national recommendation and their provincial universal rotavirus vaccination program. Nurses had higher knowledge scores than physicians in the postprogram survey (p<0.001). Parents of young infants were also more knowledgeable about rotavirus and rotavirus vaccine in the two areas where universal programs were in place (p<0.001). CONCLUSIONS: Implementation of a universal rotavirus vaccination program was associated with an increase in knowledge and more positive attitudes toward rotavirus vaccine amongst parents of eligible infants. Nurses involved in a public health-delivered vaccination program were more knowledgeable and had more positive attitudes toward the vaccine than physicians in a jurisdiction where vaccine was physician-delivered.

The role of healthcare provider attitudes in increasing willingness to accept seasonal influenza vaccine policy changes.

BACKGROUND: This research explored the role of attitudes in acceptance of organizational change initiatives. METHODS: A survey assessed factors associated with health care provider (HCP) likelihood to accept seasonal influenza vaccine policy changes. We evaluated the impact of knowledge and individual attitudes on this outcome measure. RESULTS: Knowledge of seasonal influenza vaccine and influenza recommendations was a significant predictor of HCP's attitudes toward vaccine at the individual (p<0.001), organizational (p<0.05), and legislative level (p<0.05). Mixed results were obtained when investigating the impact of knowledge on actual willingness to accept vaccine, suggesting that knowledge was only a significant predictor at the organizational (p<0.05) and legislative levels (p<0.05). Attitudes fully mediated the impact of knowledge at both the organizational and legislative levels. INTERPRETATION: Knowledge of seasonal influenza and vaccine recommendations is an important, but insufficient predictor of willingness to accept policy change.

Knowledge, attitudes, beliefs, and behaviors of pregnant women approached to participate in a Tdap maternal immunization randomized, controlled trial.

Immunization with pertussis vaccine during pregnancy is recommended in a number of countries to prevent newborn deaths from whooping cough. In some jurisdictions, vaccine uptake during pregnancy is low. We undertook a survey of the knowledge, attitudes, beliefs, and behaviors of pregnant women who had been approached to participate in a randomized, controlled trial of tetanus-diphtheria-acellular pertussis (Tdap) vaccine during pregnancy. A total of 346 women completed the survey. Knowledge about pertussis and pertussis vaccine was generally low; the mean number of correct answers was 10.65 out of 19 questions. Attitudes toward maternal immunization were generally favorable; 51.7%-94.7% of women had positive responses to 10 attitudinal statements. Substantial uncertainty was shown in responses to a number of the attitudinal statements related to vaccination during pregnancy; 22.3%-45.7% neither agreed nor disagreed with the statements. Importantly, 89% of women reported that they would get immunized with pertussis vaccine during pregnancy if their physician recommended it. We conclude that a national recommendation to be immunized with pertussis vaccine during pregnancy supported by their physicians' recommendation would be well received by Canadian women.

Impact of pharmacists as immunizers on influenza vaccination coverage in Nova Scotia, Canada.

Immunization coverage in Canada has continued to fall below national goals. The addition of pharmacists as immunizers may increase immunization coverage. This study aimed to compare estimated influenza vaccine coverage before and after pharmacists began administering publicly funded influenza immunizations in Nova Scotia, Canada. Vaccination coverage rates and recipient demographics for the influenza vaccination seasons 2010-2011 to 2012-2013 were compared with the 2013-2014 season, the first year pharmacists provided immunizations. In 2013-2014, the vaccination coverage rate for those ≥5 years of age increased 6%, from 36% in 2012-2013 to 42% (p<0.001). Pharmacists administered over 78,000 influenza vaccinations, nearly 9% of the province's population over the age of five. Influenza vaccine coverage rates for those ≥65 increased by 9.8% (p<0.001) in 2013-2014 compared to 2012-2013. Influenza vaccination coverage in Nova Scotia increased in 2013-2014 compared to previous years with a universal influenza program. Various factors may have contributed to the increased coverage, including the addition of pharmacists as immunizers and media coverage of influenza related fatalities. Future research will be necessary to fully determine the impact of pharmacists as immunizers.

Impact of pharmacists as immunizers on influenza vaccination coverage in the community-setting in Nova Scotia, Canada: 2013-2015.

BACKGROUND: Annual immunization is the most effective way to prevent influenza and its associated complications. However, optimal immunization rates are not being met in Nova Scotia, Canada. Additional providers, such as pharmacists, may improve access and convenience to receive vaccines. Pharmacists began immunizing patients 5 years of age and older within the publicly funded universal influenza vaccination program during the 2013-2014 influenza season. The objective of this study was to evaluate influenza immunization coverage rates before and after pharmacists in Nova Scotia gained authority to immunize as part of the publicly funded universal influenza vaccination program. METHODS: Influenza immunization data was obtained from the Department of Health and Wellness from 2010 to 2015. Data included billing data from physicians and pharmacists, and local public health data. Vaccination coverage was calculated as proportion of vaccinations received in comparison to the total population. RESULTS: Prior to pharmacists immunizing, overall vaccination coverage for Nova Scotia residents 6 months of age and older was 35.8 % in 2012-2013, increasing to 41.8 % coverage in 2013-2014 the year pharmacists began immunizing. A decrease of 1.9 to 39.9 % was observed in 2014-2015. In patients 65 years of age and older living in the community, coverage has increased from 61.8 % in 2012-2013 to 71.6 % in 2013-2014, and again to 73.3 % in 2014-2015 with the addition of pharmacists immunizing. Prior to pharmacists immunizing the highest coverage noted for this portion of the population was 61.8 %. CONCLUSIONS: The addition of pharmacists as immunizers within a publicly funded universal influenza vaccination program was found to increase overall vaccination coverage in the first year and to maintain higher coverage rates in the second year than those observed before pharmacists began immunizing. Increases in coverage in both years were observed in the elderly. Future research will be required to determine the ongoing impact of the addition of pharmacists as immunizers and other strategies to improve vaccination coverage.

Group B streptococcal testing during pregnancy: survey of postpartum women and audit of current prenatal screening practices.

OBJECTIVE: Group B Streptococcus (GBS) can be transmitted from mother to child during delivery. At the time of the study, Nova Scotia guidelines for screening pregnant women for the presence of GBS recommended using one of two testing methods. The objective of this study was to determine the level of compliance with GBS testing recommendations and to determine women's knowledge of, attitudes towards, and beliefs about prenatal screening for this infection. METHODS: All women who gave birth at a single tertiary care unit during a seven-week period were approached to participate in the study. Study participants were interviewed using a questionnaire to determine their knowledge of, attitudes towards, and beliefs about prenatal screening. Medical and laboratory records were reviewed in order to audit the prenatal screening practices. RESULTS: A total of 24.5% of study participants were screened for the presence of GBS by culture of a vaginal-rectal swab taken at 35 37 weeks' gestation, and 75.5% were assessed using the risk factor approach. Of the women screened by culture, 19% were identified as needing antibiotic treatment compared with 25% of those screened by assessment of risk factors. Women were significantly less knowledgeable about GBS than about other specific infections, and they felt that the threat of GBS infection for their baby was lower than the threat of the other infections. However, many of these women were uncertain about the threat that GBS poses during pregnancy. CONCLUSION: Screening for GBS by culture rather than by assessing risk factors would have reduced antibiotic usage in our study population by 23%. These results indicate that all women should be counselled regarding GBS infection and should be tested using the culture-based approach at 35 to 37 weeks' gestation.

Use of lidocaine-prilocaine patch to decrease intramuscular injection pain does not adversely affect the antibody response to diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate and hepatitis B vaccines in infants from birth to six months of age.

BACKGROUND: Topical lidocaine-prilocaine (EMLA) effectively decreases the pain associated with minor procedures including immunization, although the effect on the antibody response to diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate (DTaP-IPV-Hib) and hepatitis B vaccines has not been assessed. OBJECTIVE: To measure the antibody response to DTaP-IPV-Hib and hepatitis B vaccines; to measure pain reduction associated with the use of the lidocaine-prilocaine (EMLA) patch; and to assess safety by comparing adverse reactions. PARTICIPANTS AND SETTING: One hundred nine healthy 6-month-old infants (Part A of study) and 56 healthy infants birth to 2 months of age (Part B of study) undergoing primary immunization with DTaP-IPV-Hib and hepatitis B vaccines in an ambulatory setting. DESIGN AND INTERVENTIONS: Two center, randomized, double blind, controlled trial of EMLA patch or placebo before DTaP-IPV-Hib and hepatitis B immunization. Antibody titers measured at 0 to 2, 6 and 7 months. OUTCOME MEASURES: The primary outcome measure was the antibody response to diphtheria, tetanus, pertussis antigens, Haemophilus influenzae type b and hepatitis B by enzyme immunoassay; and poliovirus 1, 2 and 3 by neutralization. The secondary outcomes were pain scores by the Modified Behavioral Pain Scale and drug- and vaccine-associated adverse events collected with a parent diary and structured questionnaire. RESULTS: There was no difference in the antibody response between the EMLA- and placebo-treated groups as assessed by geometric mean antibody titers, rates of seroconversion or the proportion of participants achieving protective or positive antibody titers postimmunization. At the 6-month visit, EMLA recipients had less pain after immunization (total pain score, 6.75 vs. 7.35; P = 0.005; pain score increase, 3.99 vs. 4.74; P = 0.004) than did placebo recipients. Skin pallor and erythema at the patch application site were more frequently reported after EMLA use. Rates of vaccine-associated adverse events were similar in the two groups. CONCLUSIONS: The EMLA patch has no adverse effect on the antibody response to the vaccine antigens, is effective in reducing pain associated with DTaP-IPV-Hib and hepatitis B immunizations and does not result in any significant or unexpected adverse reactions.