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Paul Willems - One of the best experts on this subject based on the ideXlab platform.
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immunogenicity and reactogenicity of a novel hexavalent dtpa hbv ipv hib vaccine compared to separate concomitant injections of dtpa ipv hib and hbv vaccines when administered according to a 3 5 and 11 month Vaccination Schedule
European Journal of Pediatrics, 2002Co-Authors: Maria Avdicova, Viktor Prikazský, Henrieta Hudeckova, Lode Schuerman, Paul WillemsAbstract:In an open randomised trial, 312 eligible infants were enrolled to receive either a single injection of the hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/Haemophilus influenzae b (DTPa-HBV-IPV/Hib) vaccine, or concomitant injections of commercial DTPa-IPV/Hib and HBV vaccines (comparator). Vaccines were administered at 3, 5 and 11 months of age. The statistical approach for non-inferiority showed that the DTPa-HBV-IPV/Hib vaccine was at least as immunogenic as the comparator vaccines in terms of immunogenicity of all antigens 1 month after the 2nd dose. Non-inferiority criteria were also met immediately before and 1 month after the 3rd dose for all antigens except poliovirus type 3 prior to the 3rd dose. The majority of subjects were seroprotected against diphtheria, tetanus, polyribosyl-ribitol-phosphate, hepatitis B and poliovirus after the 2nd dose and maintained seroprotective antibody levels until the 3rd dose. A marked difference was observed in anti-HBs antibody geometric mean antibody concentrations (GMCs) at 1 month after the 2nd dose (higher GMCs in DTPa-HBV-IPV/Hib group). Reactogenicity (incidence of solicited local and general symptoms) was similar between the two study groups and no vaccine-related serious adverse events occurred. Conclusion: the new diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/Haemophilus influenzae b vaccine administered at 3, 5 and 11 months of age was safe and at least as immunogenic as the comparator vaccines thus providing an effective and more comfortable option for this infant Vaccination Schedule.
Olaf Zent - One of the best experts on this subject based on the ideXlab platform.
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tick borne encephalitis tbe Vaccination applying the most suitable Vaccination Schedule
Vaccine, 2007Co-Authors: Ines Schondorf, J Beran, Dasa Cizkova, V Lesna, Angelika Banzhoff, Olaf ZentAbstract:Tick-borne encephalitis (TBE) is caused by an arthropod-borne virus, belonging to the family of Flaviviridae. In case of disease, which can lead to neurological sequelae or even fatal outcomes, only symptomatic treatment is available. TBE can be prevented by Vaccination. Various primary immunization Schedules have been developed. To identify the most suitable Schedule, the present randomised, controlled study was designed to provide data on the immune response elicited by four different immunization Schedules obtained by ELISA and by neutralization test (NT). A total of 398 healthy subjects aged ≥12 years were randomised to Vaccination according to either the rapid Schedule (Group R, Vaccination on days 0, 7 and 21), the conventional Schedule (Group C, Vaccination on days 0, 28 and 300), the modified conventional Schedule (Group M, Vaccination on days 0, 21 and 300) or the accelerated conventional Schedule (Group A, Vaccination on days 0, 14 and 300). Within 3 weeks (i.e. by day 21) antibody levels were higher in Group R and Group A than in Group M and Group C. Group R and Group C both had higher titres on days 42, 180 and 300, than Group A and Group M. The rapid Schedule thus combines the advantages of fast protection and of high titres over the observation period of 300 days.
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long term immunity after Vaccination against tick borne encephalitis with encepur using the rapid Vaccination Schedule
International Journal of Medical Microbiology Supplements, 2004Co-Authors: J Beran, Petr Douda, Dieter Gniel, Olaf ZentAbstract:148 of 157 invited adult subjects who had participated in previous studies were enrolled in this extension study for evaluation of immunogenicity and safety of the second TBE booster immunization. All subjects had been previously immunized in studies with Chiron's formerly marketed TBE vaccine (containing polygeline as the stabilizer) according to the rapid Vaccination Schedule (i.e. primary immunization on days 0, 7, 21 and first booster immunization at month 15). All subjects were administered the second booster with Chiron's new TBE vaccine, which is free of protein-derived stabilizers, 36 months after the first booster Vaccination applied at study month 15. Blood samples were taken prior to booster and 1 month later. In 145 out of 148 subjects, blood samples suitable for measurements of TBE antibodies (ELISA assay) were provided. Prior to second booster immunization with Chiron's new TBE vaccine, TBE antibodies (GMTs) had remained at a high level and were far above the detection limit of the used ELISA test. All subjects were still seropositive prior to the second booster immunization. The second booster immunization resulted in a further increase of TBE antibodies. The booster Vaccination with Chiron's new TBE vaccine was well tolerated by all the vaccinees. Neither febrile post-immunization reactions nor unexpected adverse events or serious adverse events were reported. To summarize, these data clearly show that the TBE Vaccination with this new TBE vaccine can be used safely to boost subjects pre-immunized with the former TBE vaccine formulation. Long-lasting immunity following this second TBE booster immunization can be concluded.
Wendy A Wattigney - One of the best experts on this subject based on the ideXlab platform.
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evaluation of an early two dose measles Vaccination Schedule
American Journal of Epidemiology, 2001Co-Authors: Sonja S Hutchins, Wendy A Wattigney, Anita Dezayas, Kristen Le Blond, Janet L Heath, William J Bellini, Susette Audet, Judy A Beeler, Lauri E MarkowitzAbstract:Vaccination at 6 months of age followed by routine reVaccination is recommended when exposure of infants to measles is likely. Dade County, Florida, began this early two-dose Schedule during a large epidemic in 1986-1987 (i.e., 22% of cases occurred in infants aged 6-11 months). This Schedule was continued routinely in high-risk areas. The effect of an early two-dose Schedule on measles prevention in the county was examined by comparing measles Vaccination coverage and epidemiology before (1985-1987) and after (1988-1996) the Schedule became routine. To assess serologic response, seroprevalence of measles antibody among children aged 4-6 years in 1995 was examined. To evaluate vaccine effectiveness, a case-control study was conducted among preschool-aged children. Among those aged 2 years, Vaccination coverage with > or =1 dose increased from 75% to 94% in 1996. The number of annual cases declined, and endemic measles transmission reportedly ended after 1993. Seroprevalence of plaque reduction neutralization antibody (titer > 1:120) among those receiving Vaccination according to an early two-dose Schedule and a single dose at age > or =12 months was 94% (95% confidence interval: 89, 98) and 98% (95% confidence interval: 95, 100). In these groups, vaccine effectiveness was comparably high. Early two-dose measles Vaccination is associated with improved coverage and a comparably high level of humoral immunity and clinical protection as a single dose at age > or =12 months. This strategy can be useful in areas at high risk for measles among infants.
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surveillance for poliovirus vaccine adverse events 1991 to 1998 impact of a sequential Vaccination Schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine
Pediatrics, 2001Co-Authors: Wendy A Wattigney, Gina T Mootrey, Miles M Braun, Robert ChenAbstract:Background. The elimination of wild-virus–associated poliomyelitis in the Western Hemisphere in 1991 and rapid progress in global polio eradication efforts changed the risk-benefit ratio associated with the exclusive use of oral poliovirus vaccine (OPV) for routine immunization. These changes, plus the November 1987 development of an enhanced-potency inactivated poliovirus vaccine (IPV), which poses no risk of vaccine-associated paralytic poliomyelitis (VAPP), resulted in a change in polio immunization policy in the United States. In September 1996, the Centers for Disease Control and Prevention recommended that IPV replace OPV for the first 2 doses in a sequential poliovirus vaccine Schedule. The Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system for adverse events after receipt of any US-licensed vaccine, is used to monitor postlicensure vaccine safety. Postlicensure surveillance of vaccines is important to identify new, rare, or delayed-onset adverse reactions not detected in prelicensure clinical trials or when new vaccine Schedules are adopted. Through continual monitoring of adverse events and identification of potential vaccine risks, VAERS can serve as an important resource to ensure continued public acceptance of vaccines. We compared VAERS reports after the receipt of IPV to reports after OPV in infants from 1991 through 1998. Comparisons included reports listing IPV and OPV coadministered with other vaccines. Methods. Annual reporting rates per 100 000 doses distributed within 3 severity categories (fatal, nonfatal serious, less serious) were examined. Distributions of severity categories by vaccine type, age, and time period (pre- and postrecommendation) were constructed. Safety profiles (distribution of 21 symptom groupings) for IPV and OPV reports were compared. Analysis was restricted to reports for infants 1 to 3 months old and 4 to 6 months old, corresponding generally to first- and second-dose recipients. Any notable increase in a severity or safety category for IPV compared with OPV was followed up by examining the frequency of specific symptoms, reporting source, and date of Vaccination. An important limitation of VAERS is that reports do not necessarily represent adverse events caused by vaccines. In many cases, the events are temporal associations only. Results. The annual rates of VAERS reports per 100 000 vaccine doses distributed by severity category, 1991 to 1998, were in general similar for reports after IPV compared with those after OPV. The reporting rates for poliovirus vaccine did not increase materially with the shift to IPV usage. The relative frequencies of symptoms in the fatal and nonfatal serious categories for 1998 vaccine administrations were similar to 1997 reports. Severity profiles for IPV and OPV reports in infants 1 to 3 months old and 4 to 6 months old, corresponding to first- and second-dose recipients, were remarkably similar. The frequency of symptoms listed on IPV reports categorized as fatal or serious was examined by age, vaccine combinations, and time period, and the distribution of symptoms was similar for ages 1 to 3 months and 4 to 6 months. In the postrecommendation period, the 10 most frequent symptoms reported with IPV were also reported with OPV in either similar or lower relative frequency. During the postrecommendation period, safety profiles for infants 4 to 6 months old showed a 2.5% higher proportion in the allergic reaction category for IPV than for OPV, but none of the allergic reaction reports indicated anaphylaxis. In general, the distribution of symptom groupings was not markedly different for IPV compared with OPV. No cases of VAPP were reported after the administration of IPV, whereas 5 VAPP cases were reported after the administration of OPV. Conclusions. Although VAERS is subject to the limitations of most passive surveillance systems, the large number of reports and national coverage provide a unique database for monitoring vaccine safety. There was a marked increase of IPV reports in VAERS after 1996, consistent with implementation of the Advisory Committee on Immunization Practices recommendation for the sequential IPV/OPV poliovirus Vaccination Schedule. Given the increased use of IPV, a review of potential adverse events in VAERS compared IPV with OPV reports both before and after the introduction of the sequential Vaccination Schedule. Vaccine safety surveillance indicated no adverse events patterns of potential concern following the use of IPV in infants after the introduction of the sequential Vaccination Schedule. Ongoing surveillance is documenting a decrease in VAPP. These findings provide useful information to support the Advisory Committee on Immunization Practices recommendation, made in 1999, to shift to an all-IPV Schedule.
Kobra Farrokhi - One of the best experts on this subject based on the ideXlab platform.
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vaccine associated paralytic poliomyelitis in immunodeficient children iran 1995 2008
Emerging Infectious Diseases, 2010Co-Authors: Shohreh Shahmahmoodi, Setareh Mamishi, Asghar Aghamohammadi, Nessa Aghazadeh, Hamideh Tabatabaie, Mohammad Mehdi Gooya, Seyed Mohsen Zahraei, Taha Mousavi, Maryam Yousefi, Kobra FarrokhiAbstract:To determine the prevalence of vaccine-associated paralytic poliomyelitis (VAPP) in immunodeficient infants, we reviewed all documented cases caused by immunodeficiency-associated vaccine-derived polioviruses in Iran from 1995 through 2008. Changing to an inactivated polio vaccine Vaccination Schedule and introduction of screening of neonates for immunodeficiencies could reduce the risk for VAPP infection.
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Vaccine-associated Paralytic Poliomyelitis in Immunodeficient Children, Iran, 1995–2008
'Centers for Disease Control and Prevention (CDC)', 2010Co-Authors: Shohreh Shahmahmoodi, Setareh Mamishi, Asghar Aghamohammadi, Nessa Aghazadeh, Hamideh Tabatabaie, Mohammad Mehdi Gooya, Seyed Mohsen Zahraei, Taha Mousavi, Maryam Yousefi, Kobra FarrokhiAbstract:To determine the prevalence of vaccine-associated paralytic poliomyelitis (VAPP) in immunodeficient infants, we reviewed all documented cases caused by immunodeficiency-associated vaccine-derived polioviruses in Iran from 1995 through 2008. Changing to an inactivated polio vaccine Vaccination Schedule and introduction of screening of neonates for immunodeficiencies could reduce the risk for VAPP infection
Joon Hyung Kim - One of the best experts on this subject based on the ideXlab platform.
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immunogenicity and safety of a combined dtpa ipv hib vaccine administered as a three dose primary Vaccination course in healthy korean infants phase iii randomized study
Human Vaccines & Immunotherapeutics, 2019Co-Authors: Ki Hwan Kim, Chun Soo Kim, Hwang Min Kim, Jongduck Kim, Sang Hyuk, Dong Ho Kim, Pyounghan Hwang, Jiwhan Han, Taekjin Lee, Joon Hyung KimAbstract:We assessed the immunogenicity and safety of a three-dose primary Vaccination Schedule with the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus/Haemophilus influenzae type b ...
