Ondrej Mach

World Health Organization WHO, Genève, Geneva, Switzerland

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Publications (26)132.59 Total impact

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    ABSTRACT: The World Health Organization recommends that as part of the polio end-game strategy a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries currently using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5 of full dose) IPV (fIPV) by intradermal (ID) injection may reduce costs, but its conventional administration is with Bacillus Calmette-Guerin (BCG) needle and syringe (NS), which is time consuming and technically challenging. We compared injection quality achieved with BCG NS and three needle-free jet injectors and assessed ergonomic features of the injectors.
    No preview · Article · Jul 2015 · Vaccine
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    ABSTRACT: The immunization program in Sri Lanka consistently reaches >90% coverage with oral poliovirus vaccines (OPV), and no polio supplementary vaccination campaigns have been conducted since 2003. We evaluated serological protection against polioviruses in children. A cross-sectional community-based survey was performed in three districts of Sri Lanka (Colombo, Badulla, and Killinochchi). Randomly selected children in four age groups (9-11months, 3-4years, 7-9years, and 15years) were tested for poliovirus neutralizing antibodies. All 400 enrolled children completed the study. The proportion of seropositive children for poliovirus Type 1 and Type 2 was >95% for all age groups; for poliovirus Type 3 it was 95%, 90%, 77%, and 75% in the respective age groups. The vaccination coverage in our sample based on vaccination cards or parental recall was >90% in all age groups. Most Sri Lankan children are serologically protected against polioviruses through routine immunization only. This seroprevalence survey provided baseline data prior to the anticipated addition of inactivated poliovirus vaccine (IPV) into the Sri Lankan immunization program and the switch from trivalent OPV (tOPV) to bivalent OPV (bOPV). Copyright © 2015. Published by Elsevier Ltd.
    No preview · Article · Jul 2015
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    ABSTRACT: Supplementary immunisation activities with oral poliovirus vaccines (OPVs) are usually separated by 4 week intervals; however, shorter intervals have been used in security-compromised areas and for rapid outbreak responses. We assessed the immunogenicity of monovalent type-1 oral poliovirus vaccine (mOPV1) given at shorter than usual intervals in Karachi, Pakistan. This was a multicentre, randomised, controlled, four-arm, open-label, non-inferiority trial done at five primary health-care centres in low-income communities in and around Karachi, Pakistan. Eligible participants were healthy newborn babies with a birthweight of at least 2·5 kg, for whom informed consent was provided by their parent or guardian, and lived less than 30 km from the study clinic. After receiving a birth dose of trivalent OPV, we enrolled and randomly assigned newborn babies (1:1:1:1) to receive two doses of mOPV1 with an interval of 1 week (mOPV1-1 week), 2 weeks (mOPV1-2 weeks), or 4 weeks (mOPV1-4 weeks) between doses, or two doses of bivalent OPV (bOPV) with an interval of 4 weeks between doses (bOPV-4 weeks). We gave the first study dose of OPV at age 6 weeks. We did the randomisation with a centrally generated, computerised allocation sequence with blocks of 16; participants' families and study physicians could not feasibly be masked to the allocations. Trial participants were excluded from local supplementary immunisation activities during the study period. The primary outcome was non-inferiority (within a 20% margin) between groups in seroconversion to type-1 poliovirus. The primary and safety analyses were done in the per-protocol population of infants who received all three doses of vaccine. This trial is registered with ClinicalTrials.gov, number NCT01586572, and is closed to new participants. Between March 1, 2012, and May 31, 2013, we enrolled 1009 newborn babies, and randomly assigned 829 (82%) to treatment. 554 (67%) of the 829 babies were included in the per-protocol analysis. Proportions of seroconversion to type-1 poliovirus were 107/135 (79%, 95% CI 72·4-86·1) with mOPV1-1 week, 108/135 (80%, 73·2-86·8) with mOPV1-2 weeks, 129/148 (87%, 80·9-92·0) with mOPV1-4 weeks, and 107/136 (79%, 71·8-85·6) with bOPV-4 weeks. Non-inferiority was shown between groups and no significant differences were noted. Ten participants died during the trial. Seven of these deaths occurred during the lead-in period before randomisation (two from diarrhoea, five from unknown causes). Three infants died from sepsis after random assignment. No deaths were attributed to the procedures or vaccines. Additionally, we noted no events of vaccine-associated paralysis. We identified no significant differences in responses to mOPV1 given with shorter intervals between doses than with the standard 4 week intervals. The short-interval strategy could be particularly beneficial when temporary windows of opportunity for safe access can be granted in areas of conflict-eg, during cease-fire periods. In such situations, we recommend shortening the interval between OPV doses to 7 days. World Health Organization. Copyright © 2015 World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved. Published by Elsevier Ltd.. All rights reserved.
    No preview · Article · Jun 2015 · The Lancet Infectious Diseases
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    ABSTRACT: Reaching high population immunity against polioviruses (PV) is essential to achieving global polio eradication. Efficacy of oral poliovirus vaccine (OPV) varies and is lower among children living in tropical areas with impoverished environments. Malnutrition found as a risk factor for lower serological protection against PV. We compared whether inactivated polio vaccine (IPV) can be used to rapidly close the immunity gap among chronically malnourished (stunted) infants in Pakistan who will not be eligible for the 14 week IPV dose in routine EPI schedule. A phase 3, multicenter 4-arm randomized controlled trial conducted at five Primary Health Care (PHC) centers in Karachi, Pakistan. Infants, 9-12 months were stratified by length for age Z score into chronically malnourished and normally nourished. Infants were randomized to receive one dose of either bivalent OPV (bOPV) alone or bOPV+IPV. Baseline seroprevalence of PV antibodies and serum immune response to study vaccine dose were assessed by neutralization assay. Vaccine PV shedding in stool was evaluated 7 days after a bOPV challenge dose. Sera and stool were analyzed from 852/928 (92%) enrolled children. At baseline, the seroprevalence was 85.6% (n=386), 73.6% (n=332), and 70.7% (n=319) in malnourished children against PV types 1, 2 and 3 respectively; and 94.1% (n=448), 87.0% (n=441) and 83.6% (n=397) in the normally nourished group (p<0.05). Children had previously received 9-10 doses of bOPV (80%) or tOPV (20%). One dose of IPV+bOPV given to malnourished children increased their serological protection (PV1, n=201, 97.6%; PV2, n=198, 96.1% and PV3, n=189, 91.7%) to parity with normally nourished children who had not received IPV (p=<0.001). Seroconversion and boosting for all three serotypes was significantly more frequent in children who received IPV+bOPV than in those with bOPV only (p<0.001) in both strata. Shedding of polioviruses in stool did not differ between study groups and ranged from 2.4% (n=5) to 7.1% (n=15). In malnourished children the shedding was reduced after bOPV+IPV compared to bOPV only. Chronically malnourished infants were more likely to be unprotected against polioviruses than normal infants. bOPV+IPV helped close the immunity gap better than bOPV alone. Copyright © 2015. Published by Elsevier Ltd.
    Full-text · Article · Apr 2015 · Vaccine
  • O. Mach · R.W. Sutter · T.J. John
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    ABSTRACT: Poliomyelitis, an acute communicable disease affecting primarily children with the major manifestation of muscle paralysis, is caused by an enterovirus - poliovirus - with previously worldwide distribution. The development of first inactivated, and then attenuated, live poliovirus vaccines in the 1950s was an historic public health achievement of the twentieth century. Although polio has been eliminated from most of the world, as of June 2014 it remains endemic in three countries (Afghanistan, Pakistan and Nigeria); and exportations of poliovirus into previously polio-free countries occur frequently, causing large outbreaks if the virus reaches areas with low population immunity. Lessons about research ethics, the selection of appropriate vaccine types for different populations, and the importance of reducing unintended side effects such as vaccine virus-induced paralysis are highlighted in this article.
    No preview · Chapter · Jan 2015
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    ABSTRACT: The World Health Organization recommends that, as part of the new polio endgame, a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5th of full dose) IPV (fIPV) intradermally may reduce costs, but its administration is cumbersome with BCG needle and syringe. We evaluated performance of two newly developed intradermal-only jet injectors and compared the immune response induced by fIPV with that induced by full-dose IPV.Methods Children between 12 and 20 months of age, who had previously received two doses of OPV, were enrolled in Camaguey, Cuba. Subjects received a single dose of IPV (either full-dose IPV intramuscularly with needle and syringe or fIPV intradermally administered with one of two new injectors or with BCG needle or a conventional needle-free injector). Serum was tested for presence of poliovirus neutralizing antibodies on day 0 (pre-IPV) and on days 3, 7 and 21 (post-vaccination).ResultsComplete data were available from 74.2% (728/981) subjects. Baseline median antibody titers were 713, 284, and 113 for poliovirus types 1, 2, and 3, respectively. Seroprevalence at study end were similar across the intervention groups (≥94.8%). The immune response induced with one new injector was similar to BCG needle and to the conventional injector; and superior to the other new injector. fIPV induced significantly lower boosting response compared to full-dose IPV. No safety concerns were identified.InterpretationOne of the two new injector demonstrated its ability to streamline intradermal fIPV administration, however, further investigations are needed to assess the potential contribution of fIPV in the polio endgame plan.
    Full-text · Article · Nov 2014 · Vaccine
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    ABSTRACT: Background: Despite substantial progress toward eradication of poliomyelitis, the risk of poliomyelitis outbreaks resulting from virus importations into polio-free areas persists. We reviewed the changing epidemiology of outbreaks in the final stages of the eradication initiative. Methods: Available literature on outbreaks of poliomyelitis caused by wild polioviruses between 1996 and 2012 was reviewed. Results: During this period, there were 22 outbreaks involving 39 countries. Outbreaks ranged in size from 1 to 1335 cases. These outbreaks caused 4571 cases, representing 21% of all cases reported during this period. Five outbreaks involved multiple countries. In 76% of outbreaks (16/21) with a known age distribution, cases concentrated among children aged <5 years; in 19% (4/21), most cases were among adolescents and adults. The outbreaks among adolescents and adults were associated with higher case-fatality ratios, ranging from 12% in Albania in 1994 to 41% in the Republic of Congo in 2010. The majority of outbreaks were controlled within 6 months with oral poliovirus vaccine. Conclusions: Importations resulting in epidemic transmission of wild poliovirus caused thousands of cases of paralysis often in countries where poliomyelitis had not occurred for many years. The changing epidemiology, with cases and higher case-fatality ratios among adults, increased the severity of these outbreaks.
    No preview · Article · Nov 2014 · The Journal of Infectious Diseases
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    ABSTRACT: Polio eradication requires the removal of all polioviruses from human populations, whether wild poliovirus or those emanating from the oral poliovirus vaccine (OPV). The Polio Eradication & Endgame Strategic Plan 2013–2018 provides a framework for interruption of wild poliovirus transmission in remaining endemic foci and lays out a plan for the new polio end game, which includes the withdrawal of Sabin strains, starting with type 2, and the introduction of inactivated poliovirus vaccine, for risk mitigation purposes. This report summarizes the rationale and evidence that supports the policy decision to switch from trivalent OPV to bivalent OPV and to introduce 1 dose of inactivated poliovirus vaccine into routine immunization schedules, and it describes the proposed implementation of this policy in countries using trivalent OPV.
    No preview · Article · Nov 2014 · The Journal of Infectious Diseases
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    ABSTRACT: Background: Inactivated poliovirus vaccine (IPV) is rarely used in tropical developing countries. To generate additional scientific information, especially on the possible emergence of vaccine-derived polioviruses (VDPVs) in an IPV-only environment, we initiated an IPV introduction project in Yogyakarta, an Indonesian province. In this report, we present the coverage, immunity, and VDPV surveillance results. Methods: In Yogyakarta, we established environmental surveillance starting in 2004; and conducted routine immunization coverage and seroprevalence surveys before and after a September 2007 switch from oral poliovirus vaccine (OPV) to IPV, using standard coverage and serosurvey methods. Rates and types of polioviruses found in sewage samples were analyzed, and all poliovirus isolates after the switch were sequenced. Results: Vaccination coverage (>95%) and immunity (approximately 100%) did not change substantially before and after the IPV switch. No VDPVs were detected. Before the switch, 58% of environmental samples contained Sabin poliovirus; starting 6 weeks after the switch, Sabin polioviruses were rarely isolated, and if they were, genetic sequencing suggested recent introductions. Conclusions: This project demonstrated that under almost ideal conditions (good hygiene, maintenance of universally high IPV coverage, and corresponding high immunity against polioviruses), no emergence and circulation of VDPV could be detected in a tropical developing country setting.
    Full-text · Article · Nov 2014 · The Journal of Infectious Diseases
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    ABSTRACT: Background: In 2009, enhanced poliovirus surveillance was established in polio-endemic areas of Uttar Pradesh and Bihar, India, to assess poliovirus infection in older individuals. Methods: In Uttar Pradesh, stool specimens from asymptomatic household and neighborhood contacts of patients with laboratory-confirmed polio were tested for polioviruses. In Bihar, in community-based surveillance, children and adults from 250 randomly selected households in the Kosi River area provided stool and pharyngeal swab samples that were tested for polioviruses. A descriptive analysis of surveillance data was performed. Results: In Uttar Pradesh, 89 of 1842 healthy contacts of case patients with polio (4.8%) were shedding wild poliovirus (WPV); 54 of 85 (63.5%) were ≥5 years of age. Shedding was significantly higher in index households than in neighborhood households (P<.05). In Bihar, 11 of 451 healthy persons (2.4%) were shedding WPV in their stool; 6 of 11 (54.5%) were ≥5 years of age. Mean viral titer was similar in older and younger children. Conclusions: A high proportion of persons≥5 years of age were asymptomatically shedding polioviruses. These findings provide indirect evidence that older individuals could have contributed to community transmission of WPV in India. Polio vaccination campaigns generally target children<5 years of age. Expanding this target age group in polio-endemic areas could accelerate polio eradication.
    No preview · Article · Nov 2014 · The Journal of Infectious Diseases
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    ABSTRACT: Background: Persons with primary immune deficiency disorders (PIDD) who receive oral poliovirus vaccine (OPV) may transmit immunodeficiency-associated vaccine-derived polioviruses (iVDPVs) and cause paralytic polio. The objective of this study was to identify children with PIDD in Bangladesh, and estimate the proportion with chronic poliovirus excretion. Methods: Patients admitted at 5 teaching hospitals were screened for PIDD according to standardized clinical case definitions. PIDD was confirmed by age-specific quantitative immunoglobulin levels. Stool specimens were collected from patients with confirmed PIDD. Results: From February 2011 through January 2013, approximately 96 000 children were screened, and 53 patients were identified who met the clinical case definition for PIDD. Thirteen patients (24%) had age-specific quantitative immunoglobulins results that confirmed PIDD. Of these, 9 (69%) received OPV 3-106 months before stool specimen collection. Among 11 patients, stool specimens from 1 patient tested positive for polioviruses 34 months after OPV ingestion. However, the poliovirus isolate was not available for genetic sequencing, and a subsequent stool specimen 45 days later was negative. Conclusions: The risk of chronic poliovirus excretion among children with PIDD in Bangladesh seems to be low. The national polio eradication program should incorporate strategies for screening for poliovirus excretion among patients with PIDD.
    No preview · Article · Nov 2014 · The Journal of Infectious Diseases
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    ABSTRACT: Background: Persons with primary immune deficiency disorders (PID), especially those disorders affecting the B-cell system, are at substantially increased risk of paralytic poliomyelitis and can excrete poliovirus chronically. However, the risk of prolonged or chronic excretion is not well characterized in developing countries. We present a summary of a country study series on poliovirus excretion among PID cases. Methods: Cases with PID from participating institutions were enrolled during the first year and after obtaining informed consent were tested for polioviruses in stool samples. Those cases excreting poliovirus were followed on a monthly basis during the second year until 2 negative stool samples were obtained. Results: A total of 562 cases were enrolled in Bangladesh, China, Iran, Philippines, Russia, Sri Lanka, and Tunisia during 2008-2013. Of these, 17 (3%) shed poliovirus, including 2 cases with immunodeficient vaccine-derived poliovirus. Poliovirus was detected in a single sample from 5/17 (29%) cases. One case excreted for more than 6 months. None of the cases developed paralysis during the study period. Conclusions: Chronic polioviruses excretion remains a rare event even among individuals with PID. Nevertheless, because these individuals were not paralyzed they would have been missed by current surveillance; therefore, surveillance for polioviruses among PID should be established.
    No preview · Article · Nov 2014 · The Journal of Infectious Diseases
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    Full-text · Article · Apr 2014 · The Lancet Infectious Diseases
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    Full-text · Article · Apr 2014 · International Journal of Infectious Diseases
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    ABSTRACT: Since the launch of the Global Polio Eradication Initiative (GPEI) in 1988, circulation of indigenous wild poliovirus (WPV) has continued without interruption in only three countries: Afghanistan, Nigeria, and Pakistan. During April-December 2013, a polio outbreak caused by WPV type 1 (WPV1) of Nigerian origin resulted in 217 cases in or near the Horn of Africa, including 194 cases in Somalia, 14 cases in Kenya, and nine cases in Ethiopia (all cases were reported as of March 10, 2014). During December 14-18, 2013, Kenya conducted the first-ever campaign providing inactivated poliovirus vaccine (IPV) together with oral poliovirus vaccine (OPV) as part of its outbreak response. The campaign targeted 126,000 children aged ≤59 months who resided in Somali refugee camps and surrounding communities near the Kenya-Somalia border, where most WPV1 cases had been reported, with the aim of increasing population immunity levels to ensure interruption of any residual WPV transmission and prevent spread from potential new importations. A campaign evaluation and vaccination coverage survey demonstrated that combined administration of IPV and OPV in a mass campaign is feasible and can achieve coverage >90%, although combined IPV and OPV campaigns come at a higher cost than OPV-only campaigns and require particular attention to vaccinator training and supervision. Future operational studies could assess the impact on population immunity and the cost-effectiveness of combined IPV and OPV campaigns to accelerate interruption of poliovirus transmission during polio outbreaks and in certain areas in which WPV circulation is endemic.
    No preview · Article · Mar 2014 · MMWR. Morbidity and mortality weekly report
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    ABSTRACT: SUMMARY Since 2004, efforts to improve poliovirus detection have significantly increased the volume of specimen testing from acute flaccid paralysis (AFP) patients in India. One option to decrease collection and testing burden would be collecting only a single stool specimen instead of two. We investigated stool specimen sensitivity for poliovirus detection in India to estimate the contribution of the second specimen. We reviewed poliovirus isolation data for 303984 children aged <15 years with AFP during 2000-2010. Using maximum-likelihood estimation, we determined specimen sensitivity of each stool specimen, combined sensitivity of both specimens, and sensitivity added by the second specimen. Of 5184 AFP patients with poliovirus isolates, 382 (7·4%) were identified only by the second specimen. Sensitivity was 91·4% for the first specimen and 84·5% for the second specimen; the second specimen added 7·3% sensitivity, giving a combined sensitivity of 98·7%. Combined sensitivity declined, and added sensitivity increased, as the time from paralysis onset to stool collection increased (P = 0·032). The sensitivity added by the second specimen is important to detect the last chains of poliovirus transmission and to achieve certification of polio eradication. For sensitive surveillance, two stool specimens should continue to be collected from each AFP patient in India.
    No preview · Article · Apr 2013 · Epidemiology and Infection
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    ABSTRACT: Persons with primary immunodeficiency disorders (PIDD) who receive oral poliovirus vaccine (OPV) or are household contacts of OPV recipients are at risk of excreting immunodeficiency-associated vaccine-derived polioviruses (iVDPVs). iVDPVs can be transmitted and cause paralytic polio. The objective of this study was to determine the feasibility of identifying infants and young children with PIDD in Bangladesh, and among those identified, to estimate the proportion excreting iVDPVs. Patients admitted at 5 referral and teaching hospitals from the hospital catchment area were screened for PIDD using a standardized clinical case definition. PIDD was confirmed using results of testing for age-specific quantitative immunoglobulins (QIGs) levels. Stool specimens were collected according to WHO guidelines from children with confirmed PIDD. During February-July 2009, 13 patients were identified who met the clinical case definition for PIDD; their median age was 1.4 years (range: 2 months to 10 years). Six (46%) of the patients had age-specific QIG results that confirmed PIDD. Stool specimens from four patients tested negative for polio vaccine viruses. All four had received OPV between 50 and 264 days prior to study recruitment. Identifying children with PIDD at referral and teaching hospitals in Bangladesh is feasible, but a larger number of patients is needed to estimate the risk for iVDPV excretion. The national polio eradication program should expand surveillance for PIDD case-patients and regularly test persons with PIDD for poliovirus excretion. These efforts will be essential for developing effective prevention and control strategies following OPV cessation, especially for densely populated and tropical countries like Bangladesh where even a minimal iVDPV risk could have significant public health consequences.
    Full-text · Article · Jun 2012 · Vaccine
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    ABSTRACT: Despite recommendations from WHO to conduct measles outbreak response vaccination campaigns based on the age distribution of cases at the beginning of an outbreak, few data exist to specifically examine whether the age distribution of cases remains constant over time in a measles outbreak. This analysis explores this question with use of measles outbreak surveillance data from Bangladesh from the period 2004–2006. Pearson χ2 tests were conducted of age distributions over 2 periods during 41 large laboratory-confirmed measles outbreaks. Statistically significant changes in age distribution over time were observed in 24% of the outbreaks. No single pattern was detected in the shifts in age distribution; however, an increase in the proportion of cases occurring among infants <9 months of age was evident in 6 outbreaks. These findings suggest a need to consider the possibility of a shift in the age distribution over time when planning an outbreak response vaccination campaign.
    Full-text · Article · Jul 2011 · The Journal of Infectious Diseases
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    ABSTRACT: In 2005, the World Health Assembly endorsed a global goal of 90% reduction in measles mortality from 2000 to 2010. Substantial progress has been made toward achieving this goal in countries of the South-East Asia Region (SEAR). More than 120 million children received a second dose of measles-containing vaccine during supplemental immunization activities conducted from 2000 to 2008; routine first-dose measles-containing vaccine coverage increased from 63% in 2000 to 75% by 2008; and measles surveillance is supported in all countries by the Measles-Rubella Laboratory Network. Overall, the estimated number of measles deaths decreased by 46% from 2000 to 2008, and all countries with the exception of India have already achieved the 90% mortality reduction target. Sustained political and financial commitment from SEAR countries is needed to achieve regional measles mortality reduction and elimination.
    Preview · Article · Jul 2011 · The Journal of Infectious Diseases
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    ABSTRACT: The Government of Nepal is interested in preventing congenital rubella syndrome (CRS). Surveillance data were analyzed and studies conducted to assess the burden of rubella and CRS and aid in developing a rubella vaccination strategy. (1) Analysis of rubella cases reported through measles surveillance, 2004-2009; (2) in 2008, rubella seroprevalence among women 15 to 39 years of age was evaluated; and (3) in 2009, children attending a school for the deaf were examined for ocular defects associated with CRS. From 2004-2009, there were 3,710 confirmed rubella cases and more than 95% of these cases were less than 15 years of age. Of 2,224 women of childbearing age (WCBA) tested for anti-rubella IgG, 2,020 (90.8%) were seropositive. Using a catalytic infection model, approximately 1,426 infants were born with CRS (192/100,000 live births) in 2008. Among 243 students attending a school for the deaf, 18 (7.4%) met the clinical criteria for CRS. Rubella and CRS were documented as significant public health problems in Nepal. A comprehensive approach is necessary, including introducing rubella vaccine in the routine program, assuring immunity among WCBA, strengthening routine immunization, integrating rubella surveillance with measles case-based surveillance, and establishing CRS surveillance.
    Full-text · Article · Jul 2011 · The Journal of Infectious Diseases