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21. Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Con Full Text available with Trip Pro

Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Con Vaccines against human papillomavirus (HPV), tetanus, diphtheria, pertussis (Tdap) and Neisseria meningitidis are widely recommended in adolescents. A phase-4 observer-blind study was performed to investigate the impact of concomitant

2019 Infectious diseases and therapy Controlled trial quality: uncertain

22. Risk of Measles and Diphtheria Introduction and Transmission on Bonaire, Caribbean Netherlands, 2018. Full Text available with Trip Pro

Risk of Measles and Diphtheria Introduction and Transmission on Bonaire, Caribbean Netherlands, 2018. Endemic transmission of measles has been reestablished in Venezuela, and outbreaks of diphtheria remain ongoing across Latin America (LA). Hence, a large cross-sectional population-based serosurveillance study was conducted on Bonaire, one of the Dutch Leeward Antilles, to assess specific age and population groups at risk. Participants (aged 0-90 years) donated a blood sample and completed (...) a questionnaire (n = 1,129). Antibodies against measles and diphtheria were tested using bead-based multiplex immunoassays. Our data revealed that immunity against measles is suboptimal, especially for those aged less than 5 years from Suriname, Aruba, and former Dutch Antilles (SADA), and adolescents from LA; and against diphtheria for persons aged more than 30 years, particularly among females and residents from SADA and LA. As refugees arrive persistently, health authorities on the Dutch Leeward Antilles

2019 American Journal of Tropical Medicine & Hygiene

23. Real-time analysis of the diphtheria outbreak in forcibly displaced Myanmar nationals in Bangladesh. Full Text available with Trip Pro

Real-time analysis of the diphtheria outbreak in forcibly displaced Myanmar nationals in Bangladesh. Between August and December 2017, more than 625,000 Rohingya from Myanmar fled into Bangladesh, settling in informal makeshift camps in Cox's Bazar district and joining 212,000 Rohingya already present. In early November, a diphtheria outbreak hit the camps, with 440 reported cases during the first month. A rise in cases during early December led to a collaboration between teams from Médecins (...) sans Frontières-who were running a provisional diphtheria treatment centre-and the London School of Hygiene and Tropical Medicine with the goal to use transmission dynamic models to forecast the potential scale of the outbreak and the resulting resource needs.We first adjusted for delays between symptom onset and case presentation using the observed distribution of reporting delays from previously reported cases. We then fit a compartmental transmission model to the adjusted incidence stratified

2019 BMC Medicine

24. Immunogenicity and safety of the diphtheria, pertussis, tetanus and inactivated poliovirus vaccine when co-administered with the human rotavirus vaccine (Rotarix) in healthy Japanese infants: a phase IV randomized study. Full Text available with Trip Pro

Immunogenicity and safety of the diphtheria, pertussis, tetanus and inactivated poliovirus vaccine when co-administered with the human rotavirus vaccine (Rotarix) in healthy Japanese infants: a phase IV randomized study. Rotavirus infections have been reported to account for 40-50% of all hospitalized acute gastroenteritis cases in young children (<5 years) in Japan. Since 2011, Rotarix containing the live attenuated human rotavirus RIX4414 strain (HRV) has been licensed in Japan for infants (...) . Vaccination against rotavirus is optional in Japan whereas administration of diphtheria, pertussis, tetanus, and inactivated poliovirus (DPT-IPV) vaccine is part of the national routine immunization program. In this open-label, randomized, controlled, multicenter study, we evaluated the immunogenicity and safety of the DPT-IPV vaccine (Squarekids) administered concomitantly or staggered with the liquid HRV (Rotarix) vaccine in healthy Japanese infants. A total of 292 infants aged 6-12 weeks were randomly

2019 Human vaccines & immunotherapeutics Controlled trial quality: uncertain

25. Impact of nutritional supplementation during pregnancy on antibody responses to diphtheria-tetanus-pertussis vaccination in infants: A randomised trial in The Gambia. Full Text available with Trip Pro

Impact of nutritional supplementation during pregnancy on antibody responses to diphtheria-tetanus-pertussis vaccination in infants: A randomised trial in The Gambia. Exposure to a nutritionally deficient environment during fetal life and early infancy may adversely alter the ontogeny of the immune system and affect an infant's ability to mount an optimal immune response to vaccination. We examined the effects of maternal nutritional supplementation during pregnancy on infants' antibody (...) responses to the diphtheria-tetanus-pertussis (DTP) vaccine included in the Expanded Programme on Immunisation (EPI).The Early Nutrition and Immune Development (ENID) trial was a randomised, partially blinded trial conducted between April 2010 and February 2015 in the rural West Kiang region of The Gambia, a resource-poor region affected by chronic undernutrition. Pregnant women (<20 weeks' gestation) with a singleton pregnancy (n = 875) were randomised to receive one of four supplements: iron-folic

2019 PLoS medicine Controlled trial quality: predicted high

26. Global Epidemiology of Diphtheria, 2000-2017<sup>1</sup>. Full Text available with Trip Pro

Global Epidemiology of Diphtheria, 2000-20171. In 2017, a total of 8,819 cases of diphtheria were reported worldwide, the most since 2004. However, recent diphtheria epidemiology has not been well described. We analyzed incidence data and data from the literature to describe diphtheria epidemiology. World Health Organization surveillance data were 81% complete; completeness varied by region, indicating underreporting. As national diphtheria-tetanus-pertussis (DTP) 3 coverage (...) diphtheria incidence. Collection and use of data on subnational and booster dose coverage, enhanced laboratory capacity, and case-based surveillance would improve data quality.

2019 Emerging Infectious Diseases

27. Improved quadruplex real-time PCR assay for the diagnosis of diphtheria. Full Text available with Trip Pro

Improved quadruplex real-time PCR assay for the diagnosis of diphtheria. Introduction. Diphtheria is caused by toxigenic strains of Corynebacterium diphtheriae, Corynebacterium ulcerans and Corynebacterium pseudotuberculosis. For diagnostic purposes, species identification and detection of toxigenic strains (diphtheria toxin (tox)-positive strains) is typically performed using end-point PCR. A faster quadruplex real-time PCR (qPCR) was recently developed (De Zoysa et al. J.Med.Microbiol (...) was assessed.Results. The method allows detection of the tox gene and distinguishing C. diphtheriae (including the newly described species Corynebacterium belfantii) from C. ulcerans and C. pseudotuberculosis. Complete diagnostic specificity, sensitivity and experimental robustness were demonstrated. The lower limit of detection for C. diphtheriae, C. ulcerans and tox targets was 1.86 genome copies per 5 µl reaction volume. The method was successfully used on two distinct qPCR technologies (LightCycler 480, Roche

2019 Journal of Medical Microbiology

28. A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. Full Text available with Trip Pro

A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. This study was conducted to assess the immunogenicity and safety of GC1107 (adult tetanus diphtheria [Td] vaccine). The primary goal was to evaluate the non-inferiority of the immunogenicity of GC1107 compared to the control vaccine. Additionally, the safety profiles of GC1107 and the control vaccine were compared.The subjects were adults ≥ 18 years old who were (...) not injected with Td or adult tetanus-diphtheria-pertussis (TdaP) vaccine within the recent 5 years. A total of 253 subjects were enrolled and randomized to either the GC1107 group or the control group. For immunogenicity assessment, blood samples were collected at baseline and 28 days after vaccination and antibody titer of diphtheria and tetanus were assessed.The seroprotection rates of diphtheria and tetanus were 89.76% and 91.34%, respectively, in the GC1107 group, and 87.80% and 86.99% in the control

2019 Journal of Korean medical science Controlled trial quality: uncertain

29. Determinants of delayed or incomplete diphtheria-tetanus-pertussis vaccination in parallel urban and rural birth cohorts of 30,956 infants in Tanzania. Full Text available with Trip Pro

Determinants of delayed or incomplete diphtheria-tetanus-pertussis vaccination in parallel urban and rural birth cohorts of 30,956 infants in Tanzania. Delayed vaccination increases the time infants are at risk for acquiring vaccine-preventable diseases. Factors associated with incomplete vaccination are relatively well characterized in resource-limited settings; however, few studies have assessed immunization timeliness.We conducted a prospective cohort study examining Diphtheria-Tetanus

2019 BMC Infectious Diseases Controlled trial quality: uncertain

30. Clinico-epidemiological profile and predictors of outcome in children with diphtheria: a study from northern India. (Abstract)

Clinico-epidemiological profile and predictors of outcome in children with diphtheria: a study from northern India. Diphtheria, a vaccine preventable disease in children, is still being reported from India. Details of 99 children with a clinical diagnosis of diphtheria admitted to a paediatric tertiary care teaching and referral hospital between January 2008 and December 2015 were collected retrospectively and analysed. The median (interquartile range [IQR]) age of the study group was 7.0 years (...) (IQR = 5.0-8.0 years). Nearly two-thirds were unimmunised. Clinical features included fever (97%), dysphagia (82%), sore throat (67%), bull neck (54%), stridor (40%), neuropathy (27%) and nasal discharge (14%). Throat swab for Albert stain was positive in only 21% of cases and C. diphtheriae was isolated in only 28%. Complications included airway compromise (61.7%) followed by myocarditis (35.4%), acute kidney injury (22.3%), thrombocytopenia (25.3%) and neuropathy (27.3%). In all, 66% survived, 23

2019 Tropical Doctor

31. The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial. Full Text available with Trip Pro

The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial. This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years.In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration

2019 Vaccine Controlled trial quality: uncertain

32. Comparison of Immune Responses to Two Quadrivalent Meningococcal Conjugate Vaccines (CRM197 and Diphtheria Toxoid) in Healthy Adults. Full Text available with Trip Pro

Comparison of Immune Responses to Two Quadrivalent Meningococcal Conjugate Vaccines (CRM197 and Diphtheria Toxoid) in Healthy Adults. After the introduction of the meningococcal ACWY-CRM197 conjugate vaccine (MenACWY-CRM) in 2012 and the meningococcal ACWY-diphtheria toxoid conjugate vaccine (MenACWY-DT) in 2014, immunization was recommended for certain high-risk groups including new military recruits in Korea. However, comparative immunogenicity studies for these vaccines have not been (...) between the vaccines. The proportion of seropositive subjects after vaccination ranged from 88% to 100%.Both meningococcal conjugate vaccines showed good immunogenicity in healthy Korean adults without statistically significant differences. Further investigations for serotype distribution of circulating meningococci and the immune interference between other diphtheria toxin-containing vaccines concomitantly used for military recruits are needed to optimize immunization policies.Clinical Research

2019 Journal of Korean medical science Controlled trial quality: uncertain

33. Duration of Immunity and Effectiveness of Diphtheria-Tetanus-Acellular Pertussis Vaccines in Children. (Abstract)

Duration of Immunity and Effectiveness of Diphtheria-Tetanus-Acellular Pertussis Vaccines in Children. The United States has experienced a nationwide resurgence of pertussis since the mid-1970s, despite high estimated vaccine coverage. Short-lived immunity induced by diphtheria-tetanus-acellular pertussis (DTaP) vaccines in young children is widely believed to be responsible for this growing burden, but the duration of protection conferred by DTaP vaccines remains incompletely quantified.To

2019 JAMA pediatrics

34. Tetrabik (adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine)

Tetrabik (adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine) This English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Report on the Deliberation Results July 23, 2012 (...) Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Tetrabik Subcutaneous Injection Syringe [Non-proprietary name] Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivated Polio (Sabin strain) Combined Vaccine [Applicant] The Research Foundation for Microbial Diseases of Osaka University [Date of application] December 27, 2011 [Results of deliberation] In the meeting held on July 20, 2012, the Second Committee on New Drugs

2012 Pharmaceuticals and Medical Devices Agency, Japan

35. Quattrovac (adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine)

Quattrovac (adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine) This English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Report on the Deliberation Results July 23, 2012 (...) Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Quattrovac Subcutaneous Injection Syringe [Non-proprietary name] Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivated Polio (Sabin strain) Combined Vaccine [Applicant] The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) [Date of application] January 27, 2012 [Results of deliberation] In the meeting held on July 20, 2012, the Second Committee on New Drugs concluded

2012 Pharmaceuticals and Medical Devices Agency, Japan

36. Hexyon - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Hexyon - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed) 5 March 2013 EMA/373968/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Hexyon Common name: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) Procedure No.: EMEA/H/C/002796 Note (...) of the dossier 6 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 7 2.1. Introduction 7 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Purified Diphtheria Toxoid (PDT) 11 2.2.3. Purified Tetanus Toxoid (PTT) 12 2.2.4. Acellular Pertussis (adsorbed PTxd and adsorbed FHA) 13 2.2.5. PRP-T Drug Substance 14 2.2.6. IPV Drug Substance 16 2.2.7. HBsAg Drug Substance 16 2.2.8. Finished Medicinal Product 18 2.2.9. Discussion on chemical, pharmaceutical and biological aspects 23

2013 European Medicines Agency - EPARs

37. Hexacima - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Hexacima - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed) 5 March 2013 EMA/373868/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Hexacima Common name: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) Procedure No.: EMEA/H/C/002702 (...) of the dossier 6 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 7 2.1. Introduction 7 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Purified Diphtheria Toxoid (PDT) 11 2.2.3. Purified Tetanus Toxoid (PTT) 12 2.2.4. Acellular Pertussis (adsorbed PTxd and adsorbed FHA) 13 2.2.5. PRP-T Drug Substance 14 2.2.6. IPV Drug Substance 16 2.2.7. HBsAg Drug Substance 16 2.2.8. Finished Medicinal Product 17 2.2.9. Discussion on chemical, pharmaceutical and biological aspects 23

2013 European Medicines Agency - EPARs

38. Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose. Full Text available with Trip Pro

Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose. Reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries for boosting immunity in adolescents and adults. Although immunity to these antigens wanes with time, currently available Tdap products are not labeled for repeat administration in the United States.We (...) performed an observer-blinded, randomized controlled trial in 1330 adults aged 18 to <65 years who received either the Tdap (n = 1002) or tetanus-diphtheria (Td) (n = 328) vaccine 8 to 12 years after a dose of Tdap vaccine administered previously. Solicited adverse events following immunization were documented for 7 days after vaccination, and serious adverse events and adverse events of medical significance were documented for 6 months after vaccination. Levels of antibodies against component vaccine

2018 Journal of the Pediatric Infectious Diseases Society Controlled trial quality: uncertain

39. A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vacci Full Text available with Trip Pro

A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vacci To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPVB) vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3-4 year old children as compared to dTap-IPVR (...) (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-rubella vaccine (MMRV).This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV vaccines (dTap-IPVB or dTap-IPVR) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were

2018 Vaccine Controlled trial quality: uncertain

40. Antibody persistence and safety and immunogenicity of a second booster dose nine years after a first booster vaccination with a reduced antigen diphtheria-tetanus-acellular pertussis vaccine (Tdap) in adults. Full Text available with Trip Pro

Antibody persistence and safety and immunogenicity of a second booster dose nine years after a first booster vaccination with a reduced antigen diphtheria-tetanus-acellular pertussis vaccine (Tdap) in adults. Over the last decades, pertussis showed periodic increases in its incidence among adults, despite being a vaccine-preventable disease.This phase III, multicenter, extension study (NCT00489970) was conducted in adults from the United States, followed at Year (Y) 5 and Y9 post-vaccination (...) with a dose of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine containing either 3 (Tdap-B group) or 5 pertussis components (Tdap-A group). Willing participants in Tdap groups and newly-recruited participants (Control group) received one Tdap-B dose at Y9. Antibody persistence (at Y5 and Y9) and safety of Tdap-B at Y9 were assessed. Non-inferiority of immune response elicited by 2 Tdap doses was evaluated at Y9: (i) versus one Tdap-B dose for diphtheria and tetanus in terms

2018 Vaccine Controlled trial quality: uncertain

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