Avoidance and fear day by day in social anxiety disorder.

OBJECTIVE: Theories assert that avoidance maintains maladaptive anxiety over time, yet a clear prospective test of this effect in the day-by-day lives of people with social anxiety disorder (SAD) is lacking. METHOD: We used intensive longitudinal data to test prospective relationships between social fear and social avoidance in 32 participants with SAD who reported on a total of 4256 time points. RESULTS: Results suggested that avoidance strongly predicted future anxiety, but only in a minority of people with SAD. Relationships between anxiety and avoidance varied considerably across individuals. Pre-registered tests found that the strength of autocorrelation for social fear is a good target for future testing of prediction of exposure response. Participants with lower autocorrelations were less likely to show between-session habituation. CONCLUSIONS: Overall, results suggest avoidance maintains fear in SAD for at least some individuals, but also indicates considerable variability. Further intensive longitudinal data is needed to examine individuals with SAD across varying time courses.

Influence of a passive exoskeleton on kinematics, joint moments, and self-reported ratings during a lifting task.

It was found that the Auxivo LiftSuit reduced the load on the back and hip muscles when lifting heavy loads, but its effect on lower body kinematics, joint moments, and self-reported ratings was unclear. The purpose of this study was to assess the effect of this passive lift-exoskeleton design, on lower body kinematics, joint moments, and self-reported ratings during lifting of heavy loads. Twenty healthy subjects performed lifting of heavy loads with and without the exoskeleton under surveillance of a motion capture system. Medium and maximum level adjustments of the exoskeleton, as well as no exoskeleton use were analyzed. Our results indicate significant reduction (p <.01) in pelvis segment tilt and hip flexion ROM with the exoskeleton at maximum level adjustment in males during lifting. Lumbosacral flexion moment ranges were significantly decreased (p <.013) with the exoskeleton at maximum and medium level adjustment in males during lifting. The general user impressions were mostly positive, with participants reporting that it was easier to perform the task with the exoskeleton than without it (p <.0.001), and preferring and recommending the exoskeleton for the task. Although our findings may suggest negative effects of the Auxivo LiftSuit in males and females due to a ROM restriction and loose fit, respectively, it does not mean that the Auxivo LiftSuit is not useful for lifting tasks. Further design improvements are required to allow full range of motion of hips and pelvis, as well to provide better adjustment and level of support in female users.

Prey selection along a predators' body size gradient evidences the role of different trait-based mechanisms in food web organization.

An increase in prey richness, prey size and predator trophic position with predator body size has been consistently reported as prime features of food web organization. These trends have been explained by non-exclusive mechanisms. First, the increase in energy demand with body size determines that larger predators must reduce prey selectivity for achieving the required number of resources, being consumption relationships independent of prey traits. Second, when consumption is restricted by gape limitation, small predators are constrained to select among small prey. However, this selection weakens over large predators, which progressively consume more and larger prey. Finally, the optimal foraging mechanism predicts that larger predators optimize their diet by selecting only large prey with high energy reward. Each one of these mechanisms can individually explain the increase in prey richness, prey size and predator trophic position with predator body size but their relative importance or the direct evidence for their combined role was seldom considered. Here we use the community assembly by trait selection (CATS) theory for evaluating the support for each one of these mechanisms based on the prey selection patterns that they predict. We analyzed how prey body size and trophic guild determine prey selection by predators of increasing body size in a killifish guild from a temporary pond system. Results support the combination of the three mechanisms to explain the structural trends in our food web, although their strength is contingent on prey trophic group. Overall, high energy prey are preferred by larger predators, and small predators select small prey of all trophic status. However, large predators prefer large primary producers and avoid large carnivorous prey, probably because of the inherent risk of consuming other carnivorous. Our study provides a mechanistic understanding of how predator traits determine the selection of prey traits affecting food web assembly.

Scaling of biological rates with body size as a backbone in the assembly of metacommunity biodiversity.

The dispersal-body mass association has been highlighted as a main determinant of biodiversity patterns in metacommunities. However, less attention has been devoted to other well-recognized determinants of metacommunity diversity: the scaling in density and regional richness with body size. Among active dispersers, the increase in movement with body size may enhance local richness and decrease ß-diversity. Nevertheless, the reduction of population size and regional richness with body mass may determine a negative diversity-body size association. Consequently, metacommunity assembly probably emerges from a balance between the effect of these scalings. We formalize this hypothesis by relating the exponents of size-scaling rules with simulated trends in α-, ß- and γ-diversity with body size. Our results highlight that the diversity-body size relationship in metacommunities may be driven by the combined effect of different scaling rules. Given their ubiquity in most terrestrial and aquatic biotas, these scaling rules may represent the basic determinants-backbone-of biodiversity, over which other mechanisms operate determining metacommunity assembly. Further studies are needed, aimed at explaining biodiversity patterns from functional relationships between biological rates and body size, as well as their association with environmental conditions and species interactions.

Endodontic Tissue Regeneration: A Review for Tissue Engineers and Dentists.

The paradigm shift in the endodontic field from replacement toward regenerative therapies has witnessed the ever-growing research in tissue engineering and regenerative medicine targeting pulp-dentin complex in the past few years. Abundant literature on the subject that has been produced, however, is scattered over diverse areas of knowledge. Moreover, the terminology and concepts are not always consensual, reflecting the range of research fields addressing this subject, from endodontics to biology, genetics, and engineering, among others. This fact triggered some misinterpretations, mainly when the denominations of different approaches were used as synonyms. The evaluation of results is not precise, leading to biased conjectures. Therefore, this literature review aims to conceptualize the commonly used terminology, summarize the main research areas on pulp regeneration, identify future trends, and ultimately clarify whether we are really on the edge of a paradigm shift in contemporary endodontics toward pulp regeneration.

Post-Marketing Safety Surveillance of a Childhood Pentavalent Diphtheria-Tetanus-Acellular Pertussis-Polio and Haemophilus influenzae Type B (DTaP-IPV//Hib) Vaccine in South Korea.

INTRODUCTION: PENTAXIM™ (Sanofi), DTaP-IPV//Hib, a pentavalent combination vaccine for protection against diphtheria, tetanus, pertussis, poliomyelitis, and invasive infections caused by Haemophilus influenzae type b, has been licensed in South Korea by the Ministry of Food and Drug Safety (MFDS) on May 9, 2016, and is currently used in routine vaccination. The aim of this phase IV study, conducted as a post-licensure commitment in South Korea, was to evaluate the safety of the DTaP-IPV//Hib vaccine when administered in infants at 2, 4, and 6 months of age in the real-world clinical practice. METHODS: This multicenter, observational, post-marketing surveillance (PMS) study was conducted in real-world practice in South Korea. Infants aged 2 months or older were enrolled across seven centers from July 31, 2018 to February 11, 2020. The study outcomes included occurrence, time to onset, duration, intensity, and causality assessment (for unsolicited adverse events [AEs] only) for several pre-listed solicited injection-site and systemic reactions, unsolicited AEs, and serious adverse events (SAEs). RESULTS: Data from 619 participants were included in the safety analysis. Overall, 618 AEs were reported by 273 (44.1%) participants consisting of 121 solicited injection-site reactions (15.4%), 344 solicited systemic reactions (24.6%), and 153 unsolicited AEs (15.7%) of which, 124 were unexpected AEs (12.9%) (regardless of intensity). None of the unsolicited AEs were reported to have a causal relationship with the study vaccine. One SAE of pyrexia (solicited reaction) was reported. Most AEs were of mild intensity, and all participants recovered. CONCLUSION: This PMS study of the DTaP-IPV//Hib vaccine confirmed its safety profile in a real-life setting in South Korea and justified that the vaccine is well tolerated when used in infants aged 2 months or older for the primary series.

Evaluation of Injectable Hyaluronic Acid-Based Hydrogels for Endodontic Tissue Regeneration.

Dental pulp tissue engineering (TE) endeavors to regenerate dentin/pulp complex by combining a suitable supporting matrix, stem cells, and biochemical stimuli. Such procedures foresee a matrix that can be easily introduced into the root canal system (RCS) and tightly adhere to dentin walls to assure the dentin surface's proper colonization with progenitor cells capable of restoring the dentin/pulp complex. Herein was investigated an injectable self-setting hyaluronic acid-based (HA) hydrogel system, formed by aldehyde-modified (a-HA) with hydrazide-modified (ADH), enriched with platelet lysate (PL), for endodontic regeneration. The hydrogels' working (wT) and setting (sT) times, the adhesion to the dentine walls, the hydrogel's microstructure, and the delivery of human dental pulp cells (DPCs) were studied in vitro. Hydrogels incorporating PL showed a suitable wT and sT and a porous microstructure. The tensile tests showed that the breaking point occurs after 4.3106 ± 1.8677 mm deformation, while in the indentation test after 1.4056 ± 0.3065 mm deformation. Both breaking points occur in the hydrogel extension. The HA/PL hydrogels exhibited supportive properties and promoted cell migration toward dentin surfaces in vitro. Overall, these results support using PL-laden HA injectable hydrogels (HA/PL) as a biomaterial for DPCs encapsulation, thereby displaying great clinical potential towards endodontic regenerative therapies.

Spinal anesthesia in a patient with Charcot-Marie-Tooth disease undergoing orthopedic surgery: case report / Anestesia raquídea en un paciente con enfermedad de Charcot-Marie-Tooth sometido a cirugía ortopédica: reporte de caso

Abstract Introduction: It is uncommon to come across patients with neuromuscular diseases in the daily practice of anesthesia, given the low prevalence of those conditions. Charcot-Marie-Tooth (CMT) disease is the most frequently, caused by an inherited abnormal myelin structure pattern. In view of the low prevalence of this condition (1:25,000), there is little information, derived mostly from case reports, about the use of neuroaxial anesthesia in these patients. Case presentation: Description of a patient with underlying CMT disease compromising lower limb mobility, who comes to the emergency service due to lower limb pain. After being diagnosed with an acetabular fracture, the patient underwent orthopedic surgery under spinal anesthesia, selected based on patient comorbidities, and the immediate postoperative follow-up. Results: The anesthetic and surgical procedures proceeded uneventfully and no neuropathic worsening was observed during the next 24 hours. Conclusion: Uneventful neuroaxial anesthesia is reported in a patient with neuromuscular disease. The case contributes to show the benefits and safety of this form of anesthesia when compared with other options.

Resumen Introducción: En la práctica anestésica diaria es raro enfrentarse a pacientes con patologías neuromusculares, dada la poca pre-valencia de dichas patologías. La más frecuente de ellas es la enfermedad de Charcot-Marie-Tooth, en la cual se hereda un patrón alterado en la estructura de la mielina. Debido a la baja prevalencia de esta patología (1:25000), el uso de anestesia neuroaxial en dichos pacientes no cuenta con mucha información, y mucha de ella proviene de reportes de casos. Presentación del caso: Se describe el caso de un paciente con enfermedad de Charcot-Marie-Tooth, de base, con compromiso de la movilidad en miembros inferiores, y quien asiste a urgencias por dolor en miembro inferior. Tras ser diagnosticado con fractura de acetábulo, fue sometido a cirugía ortopédica bajo anestesia raquídea, indicada a la luz de sus comorbilidades, y el posterior seguimiento inmediato. Resultados: Se realiza el procedimiento anestésico y quirúrgico sin complicaciones, y no se presenta empeoramiento de la neuropatía en las 24 horas posteriores. Conclusiones: Se reporta un caso de anestesia neuroaxial en paciente con enfermedad neuromuscular sin incidencias, que ayuda así a ir mostrando los beneficios de la mencionada anestesia y su seguridad frente a otras opciones.

Regeneración de la pulpa dental: una revisión de la literatura / Dental pulp regeneration: a review of the literature

El objetivo del presente artículo es la revisión de la literatura desde enero 2013 hasta diciembre 2017 con el fi n de encontrar el enfoque actual de la ingeniería de tejidos para regenerar la pulpa dental. Se realizó una revisión bibliográfi ca en diciembre de 2017 en el motor de búsqueda PubMed utilizando los descriptores: dental regeneration, pulp regeneration y dental pulp regeneration. La tendencia de estos últimos cinco años está dirigida mayormente al estudio de las células madre y pocos de estos estudios se han enfocado en las moléculas de señalización. Se concluyó que las DPSC fueron las más utilizadas, los escasos estudios de andamios utilizaron colágeno, a coágulo sanguíneo, plasma rico en plaquetas y una diversidad de moléculas de señalización donde prevalece el uso de fragmentos de dentina en sus diferentes formas; se utilizó un número similar de estudios in vivo e in vitro (AU)

The aim of this paper is the literature review since January 2013 until December 2017 in order to fi nd the current approach of tissue engineering to regenerate dental pulp. A bibliographic review was made on December 2017 in the PubMed search engine using the descriptors: dental regeneration, pulp regeneration and dental pulp regeneration. The trend of the last fi ve years is mainly directed to the study of stem cells and few of these studies have focused on signaling molecules. It was concluded that the DPSC were the most used, scant scaff olding studies used collagen, a blood clot, platelet-rich plasma, and a variety of signaling molecules where the use of dentine fragments in their diff erent forms prevails; a similar number of in vivo and in vitro studies were used (AU)

Diagnóstico de conducto radicular en C en segundos molares mandibulares mediante la evidencia del ángulo obtenido: estudio piloto de validación / Diagnosis of C-shaped root canals in mandibular second molars through the evidence of the obtained angle: a pilot validation study

Antecedentes: El estándar dorado para diagnosticar segundos molarescon conducto radicular en C antes del inicio de un tratamiento endodóntico restaurador es la tomografía cone beam. La difi cultad para accedera los servicios tomográfi cos y su baja distribución en los consultorios odontológicos nos han llevado a diseñar una técnica alternativa enradiografías panorámicas nombrada «evidencia del ángulo obtenido¼(EAO). Objetivo: El objetivo de este trabajo fue crear un punto de cortey estimar la precisión diagnóstica del mismo mediante un estudio pilotocuyo resultado será utilizado en una futura investigación de validación de pruebas diagnósticas...

Background: The gold standard to diagnose second molars withC-shaped root canals prior to beginning an endodontic and restorative treatment is cone-beam tomography. Tomographic services are hard to access and have a low distribution in dental clinics this has led usto design an alternative technique in panoramic radiographs named«evidence of the obtained angle¼ (EAO). Objective: The aim of thisstudy was to create a breakpoint and estimate its diagnostic accuracy through a pilot study; its results will be used in a future investigation of validation of diagnostic tests...

The Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP~T) Vaccines: a Randomized Clinical Trial in South Korean Infants.

Recommended infant vaccination in Korea includes DTaP-IPV and Hib vaccines administered as separate injections. In this randomized, open, controlled study we assessed the non-inferiority of immunogenicity of DTaP-IPV//Hib pentavalent combination vaccine (Pentaxim™) compared with licensed DTaP-IPV and Hib (PRP~T) vaccines. We enrolled 418 healthy Korean infants to receive either separate DTaP-IPV and Hib vaccines (n = 206) or the pentavalent DTaP-IPV//Hib (n = 208) vaccine at 2, 4, 6 months of age. Antibodies to all components were measured before the first vaccination and one month after the third, and safety was assessed after each vaccination including recording of reactions by parents. We confirmed the non-inferiority of DTaP-IPV//Hib compared with DTaP-IPV and Hib vaccines; 100% of both groups achieved seroprotection against D, T, IPV and PRP~T, and 97.5%-99.0% demonstrated seroresponses to pertussis antigens. Antibody levels were similar in both groups, except for those to the Hib component, PRP~T. In separate and combined groups geometric mean concentrations of anti-PRP~T antibodies were 23.9 and 11.0 µg/mL, respectively, but 98.3% and 97.4% had titers ≥ 1 µg/mL, indicative of long-term protection. All vaccines were well tolerated, with no vaccine-related serious adverse event. Both groups had similar safety profiles, but the combined vaccine group had fewer injection site reactions. The immunological non-inferiority and similar safety profile of DTaP-IPV//Hib vaccine to separate DTaP-IPV and Hib vaccines, with the advantage of fewer injections and injection site reactions, supports the licensure and incorporation of DTaP-IPV//Hib into the Korean national vaccination schedule (Clinical trial registry, NCT01214889).

Long-term immunogenicity assessment of a DTaP-IPV//PRP-T vaccine given at 2, 4, 6 and 18-19 months of age, and immunogenicity and safety of a DTaP-IPV vaccine given as a booster dose at 4 to 6 years of age in Thai children.

Booster vaccination of infants aims to further reduce the burden of childhood infectious diseases. This study assessed the antibody persistence induced by a primary series vaccination at 2, 4, 6 months of age and a first booster at 18-19 months of age with a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b combined vaccine (DTaP-IPV//PRP-T) in 4-6 year-old Thai children (N=123). The safety and immunogenicity of a tetravalent acellular pertussis combined vaccine (containing the same DTaP-IPV antigens as the previous vaccine) given as a second booster at 4 to 6 years of age was also evaluated. Seroprotective antibody levels against diphtheria (> or = 0.01 IU/ml), tetanus (> or = 0.10 IU/ml), and polioviruses (> or = 8 1/dil) were maintained 4-6 years after primary-vaccination and first booster by > or = 92.7% of children, and anti-pertussis antibodies > or = 5 EU/ml were observed in the majority of children. The second booster with DTaP-IPV elicited a strong response for all antigens. GMT or GMC ratios for all antigens at the pre- and post-booster samples were from 4.7 to 52.5. Primary vaccination at 2, 4, 6 and a booster at 18-19 months of age with the DTaP-IPV//PRP-T vaccine induced satisfactory antibody persistence at 4-6 years of age. A second booster with DTaP-IPV induced a strong immune response and was well tolerated.

Antibody persistence after primary and booster doses of a pentavalent vaccine against diphtheria, tetanus, acellular pertussis, inactivated poliovirus, haemophilus influenzae type B vaccine among Thai children at 18-19 months of age.

The World Health Organization recommends a booster dose of a pertussis-containing vaccine for children aged 1-6 years, preferably during the second year of life. This study assessed the immunogenicity and safety of a pentavalent combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated-Hib polysaccharide antigens, [(DTaP-IPV//PRP-T (Pentaxim)], as a booster at 18-19 months of age. Participants had received primary doses of the same vaccine at 2, 4 and 6 months of age. Antibody concentrations were measured immediately before and one month after the booster dose. Adverse events were evaluated from parental reports. Geometric mean concentrations (GMCs) or titers (GMTs) decreased from post-primary to pre-booster vaccination; however, at least 94.4% of children had protective levels of anti-tetanus (> or = 0.01 IU/ml), antipoliovirus (> or = 81/dil) and anti-PRP (Hib, > or = 0.15 microg/ml) antibodies prior to the booster. Anti-diphtheria antibody titers > or = 0.01 IU/ml were also observed in the majority of children pre-booster. One month after the booster, seroprotection rates were 99.4% for PRP (> or = 1.0 microg/ml), 95.0% for diphtheria (> or = 0.10 IU/ml) and 100% for tetanus (> or = 0.1 IU/ml) and poliovirus types 1, 2, 3 (> or = 81/dil). At least 93.1% of subjects had 4 fold post-booster increases in anti-pertussis antibody titers. GMCs increased from 14.0 to 307.3 EU/ml and from 13.9 to 271.9 EU/ml for anti-PT and anti-FHA, respectively. Anti-PRP GMC increased from 1.2 to 62.2 microg/ml. The booster was well tolerated. A booster dose during the second year of life was safe and induced a strong immune response, indicative of long-term protection.

Antibody persistence at 18-20 months of age and safety and immunogenicity of a booster dose of a combined DTaP-IPV//PRP∼T vaccine compared to separate vaccines (DTaP, PRP∼T and IPV) following primary vaccination of healthy infants in the People's Republic of China.

This study assessed the antibody persistence, and the immunogenicity and safety of a booster dose of a DTaP-IPV//PRP∼T (Pentaxim®, Sanofi Pasteur's AcXim family) combined vaccine and of standalone vaccines one year after primary vaccination in the People's Republic of China. Participants (N=719) previously primed with DTaP-IPV//PRP∼T at 2, 3, 4 months (Group A, N=255), 3, 4, 5 months (Group B, N=233), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib®) and IPV (Imovax® Polio) at 3, 4, 5 months (Group C, N=231) received boosters of the same vaccines at 18-20 months of age. Seroprotection (SP) and seroconversion (SC) were determined before and 1 month after the booster. Safety was monitored from parental reports. In all groups 87.6-100% of participants had pre-booster protective anti-PRP, -diphtheria, -tetanus and -poliovirus antibody titers; post-booster, all SP rates were 100% and SC was ≥ 80.4% for anti-pertussis titers ≥ 4-fold increase. Reactogenicity was low for each group. These data support the use of the DTaP-IPV//PRP∼T vaccine in the People's Republic of China compared to separate DTaP, IPV, and PRP∼T administration in terms of both safety and immunogenicity.

A DTaP-IPV//PRP∼T vaccine (Pentaxim): a review of 16 years' clinical experience.

Owing to their low reactogenicity, confirmed efficacy and availability in combination vaccines, acellular pertussis (aP)-inactivated poliovirus (IPV) combined vaccines are now included in various national immunization programs worldwide. We provide an overview of 16 years of clinical experience with a diphtheria (D), tetanus (T), aP, IPV and Haemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (PRP∼T) combined vaccine (DTaP-IPV//PRP∼T - Pentaxim, Sanofi Pasteur, France). Good immunogenicity has been demonstrated after primary vaccination with Pentaxim, regardless of the population ethnicity and primary vaccination schedule. A booster vaccination in the second year of life also resulted in a high immune response for each antigen. Furthermore, 10 years of national surveillance in Sweden has demonstrated the effectiveness of Pentaxim in controlling pertussis. As is the case for other aP-containing combined vaccines, Pentaxim is well tolerated, with the safety profile being better than for whole-cell pertussis-containing combination vaccines for primary and booster vaccinations.

Immunogenicity and safety of an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Hib-conjugate combined vaccine (Pentaxim) and monovalent hepatitis B vaccine at 6, 10 and 14 weeks of age in infants in South Africa.

OBJECTIVE: To assess the immunogenicity and safety data for a pentavalent combination vaccine containing acellular pertussis, inactivated poliovirus, and Haemophilus influenzae (Hib) polysaccharide-conjugate antigens. METHODS: A DTaP-IPV//PRP T vaccine (Pentaxim) was given at 6, 10 and 14 weeks of age to 212 infants in South Africa. Monovalent hepatitis B vaccine was given concomitantly. Immunogenicity was assessed using seroprotection and seroconversion rates; safety was assessed by monitoring for solicited injection site and systemic adverse events, and follow-up monitoring for unsolicited adverse events and serious adverse events. RESULTS: Immunogenicity was high for each vaccine antigen, and similar to a reference study done in France using a similar (2, 3 and 4 months of age) administration schedule. After the third dose, 94.6% of participants had anti-PRP > or = 0.15 microg/ml. The anti-PRP geometric mean antibody titre (GMT) was 2.0 microg/ml. The seroprotection rates for diphtheria and tetanus (> or = 0.01 IU/ml), poliovirus types 1, 2 and 3 (> or = 8 1/dil U) and hepatitis B were all 100%. Anti-polio GMTs were very high, 1 453, 1 699 and 2 398 (1/dil U) for types 1, 2 and 3, respectively. The seroconversion/vaccine response rates to pertussis antigens (4-fold increase in antibody concentration) were 97.5% for PT and 83.9% for FHA. CONCLUSIONS: The DTaP-IPV//PRP T vaccine was highly immunogenic at 6, 10 and 14 weeks of age in infants in South Africa, was compatible with the monovalent hepatitis B vaccine, and was well tolerated.

Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China.

The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim(®)) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib(®)) and IPV (Imovax(®) Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules.

Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea.

This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV; Tetraxim™) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately. Immunogenicity was high in both groups; seroprotection and seroconversion rates of the combined vaccine (Group A) were non-inferior to the control vaccines (Group B). All subjects were seroprotected against poliovirus types 1, 2 and 3 (≥ 81/dil) and anti-diphtheria (≥ 0.01 IU/mL); 99.0% were seroprotected against tetanus (≥ 0.1 IU/mL). At least 93.6% had anti-diphtheria antibody titers ≥ 0.1 IU/mL. Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) seroconversion (≥ 4-fold increase in antibody titer) rates were 96.6% and 94.4% for Group A, 92.2% and 78.4% for Group B. Most solicited reactions occurred within 4 days of vaccination, resolved within 3 days and were mild. Severe solicited reactions occurred after ≤ 0.5% of doses in Group A and ≤ 0.9% in Group B. No withdrawals occurred because of adverse events. The DTaP-IPV combined vaccine given at 2, 4, and 6 months of age was well tolerated; immunogenicity was similar to the control vaccines.