Novel safety issues and areas that require further research Situation paper

[1]  S. Black,et al.  Narcolepsy and Pandemic Influenza Vaccination: What We Need to Know to be Ready for the Next Pandemic. , 2019, The Pediatric infectious disease journal.

[2]  H. Tinto,et al.  Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial. , 2019, The Lancet. Infectious diseases.

[3]  J. Tate,et al.  Does Rotavirus Vaccination Affect Longer-Term Intussusception Risk in US Infants? , 2019, Journal of the Pediatric Infectious Diseases Society.

[4]  S. Madhi,et al.  Evaluation of Intussusception After Oral Monovalent Rotavirus Vaccination in South Africa , 2019, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[5]  Peter G. Smith,et al.  Sensitivity and negative predictive value for a rapid dengue test. , 2019, The Lancet. Infectious diseases.

[6]  J. Tate,et al.  Approaches to monitoring intussusception following rotavirus vaccination , 2018, Expert opinion on drug safety.

[7]  E. Mignot,et al.  Autoimmunity to hypocretin and molecular mimicry to flu in type 1 narcolepsy , 2018, Proceedings of the National Academy of Sciences.

[8]  H. Larson,et al.  Vaccine confidence plummets in the Philippines following dengue vaccine scare: why it matters to pandemic preparedness , 2018, Human vaccines & immunotherapeutics.

[9]  M. Demoitié,et al.  Phase 2b placebo-controlled trial of M72/AS01E candidate vaccine to prevent active tuberculosis in adults , 2018, The New England journal of medicine.

[10]  T. Westling,et al.  Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy , 2018, The New England journal of medicine.

[11]  Eva Harris,et al.  Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines. , 2018, Vaccine.

[12]  J. Tate,et al.  Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa , 2018, The New England journal of medicine.

[13]  Alexis J Pillsbury,et al.  Safety of Human Papillomavirus Vaccines: An Updated Review , 2018, Drug Safety.

[14]  H. Feldmann,et al.  1918 H1N1 Influenza Virus Replicates and Induces Proinflammatory Cytokine Responses in Extrarespiratory Tissues of Ferrets , 2018, The Journal of infectious diseases.

[15]  W Katherine Yih,et al.  Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System , 2018, American journal of epidemiology.

[16]  M. Halloran,et al.  Antibody-dependent enhancement of severe dengue disease in humans , 2017, Science.

[17]  T. Shimabukuro,et al.  Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System. , 2017, The Journal of adolescent health : official publication of the Society for Adolescent Medicine.

[18]  G. Kang,et al.  A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants , 2017, Vaccine.

[19]  B. Choe,et al.  Epidemiological Correlation between Fecal Adenovirus Subgroups and Pediatric Intussusception in Korea , 2017, Journal of Korean medical science.

[20]  E. Harris,et al.  Immune correlates of protection for dengue: State of the art and research agenda. , 2017, Vaccine.

[21]  M. Partinen,et al.  Incidence of narcolepsy after H1N1 influenza and vaccinations: Systematic review and meta-analysis. , 2017, Sleep medicine reviews.

[22]  P. Magnus,et al.  Narcolepsy and hypersomnia in Norwegian children and young adults following the influenza A(H1N1) 2009 pandemic. , 2017, Vaccine.

[23]  R. Grais,et al.  Efficacy of a Low‐Cost, Heat‐Stable Oral Rotavirus Vaccine in Niger , 2017, The New England journal of medicine.

[24]  T. Olsson,et al.  The immunogenetics of narcolepsy associated with A(H1N1)pdm09 vaccination (Pandemrix) supports a potent gene–environment interaction , 2017, Genes and Immunity.

[25]  E. L. Goh,et al.  Complex regional pain syndrome: a recent update , 2017, Burns & Trauma.

[26]  P. Khamrin,et al.  Adenovirus infection: A potential risk for developing intussusception in pediatric patients , 2016, Journal of medical virology.

[27]  Y. Dauvilliers,et al.  CD8 T cell-mediated killing of orexinergic neurons induces a narcolepsy-like phenotype in mice , 2016, Proceedings of the National Academy of Sciences.

[28]  C. Steiner,et al.  Intussusception Rates Before and After the Introduction of Rotavirus Vaccine , 2016, Pediatrics.

[29]  Nick Andrews,et al.  The risk of intussusception following monovalent rotavirus vaccination in England: A self-controlled case-series evaluation. , 2016, Vaccine.

[30]  J. Tate,et al.  Rotavirus vaccination and intussusception – Science, surveillance, and safety: A review of evidence and recommendations for future research priorities in low and middle income countries , 2016, Human vaccines & immunotherapeutics.

[31]  F. Shann,et al.  RTS,S Malaria Vaccine and Increased Mortality in Girls , 2016, mBio.

[32]  B. Gessner,et al.  CNS infection safety signal of RTS,S/AS01 and possible association with rabies vaccine , 2016, The Lancet.

[33]  I. Abu-Arafeh,et al.  Complex regional pain syndrome in children: incidence and clinical characteristics , 2016, Archives of Disease in Childhood.

[34]  T. Hökfelt,et al.  H1N1 influenza virus induces narcolepsy-like sleep disruption and targets sleep–wake regulatory neurons in mice , 2015, Proceedings of the National Academy of Sciences.

[35]  M. Martínez-Lavín,et al.  HPV vaccination syndrome. A questionnaire-based study , 2015, Clinical Rheumatology.

[36]  C. Weinbaum,et al.  HPV Vaccination and Complex Regional Pain Syndrome: Lack of Evidence , 2015, EBioMedicine.

[37]  K. Verschueren,et al.  Investigating Reports of Complex Regional Pain Syndrome: An Analysis of HPV-16/18-Adjuvanted Vaccine Post-Licensure Data , 2015, EBioMedicine.

[38]  C. Yung,et al.  Intussusception and Monovalent Rotavirus Vaccination in Singapore: Self-Controlled Case Series and Risk-Benefit Study. , 2015, The Journal of pediatrics.

[39]  M. Partinen,et al.  Neuronal Antibodies in Children with or without Narcolepsy following H1N1-AS03 Vaccination , 2015, PloS one.

[40]  Shinn-Jang Hwang,et al.  Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. , 2015, The New England journal of medicine.

[41]  J. Mehlsen,et al.  Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus. , 2015, Vaccine.

[42]  M. Martínez-Lavín.  Hypothesis: Human papillomavirus vaccination syndrome—small fiber neuropathy and dysautonomia could be its underlying pathogenesis , 2015, Clinical Rheumatology.

[43]  David W. Smith,et al.  Intussusception is associated with the detection of adenovirus C, enterovirus B and rotavirus in a rotavirus vaccinated population. , 2014, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[44]  T. Kuiken,et al.  Evidence for influenza virus CNS invasion along the olfactory route in an immunocompromised infant. , 2014, The Journal of infectious diseases.

[45]  G. Kang,et al.  Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial , 2014, The Lancet.

[46]  Amber D. Miller,et al.  Role of innate immunity and altered intestinal motility in LPS- and MnCl2-induced intestinal intussusception in mice. , 2014, American journal of physiology. Gastrointestinal and liver physiology.

[47]  E. Belongia,et al.  Risk of intussusception after monovalent rotavirus vaccination. , 2014, The New England journal of medicine.

[48]  W Katherine Yih,et al.  Intussusception risk after rotavirus vaccination in U.S. infants. , 2014, The New England journal of medicine.

[49]  Katherine J. Lee,et al.  Intussusception risk and disease prevention associated with rotavirus vaccines in Australia's National Immunization Program. , 2013, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[50]  A. Tozzi,et al.  Assessment of causality of individual adverse events following immunization (AEFI): a WHO tool for global use. , 2013, Vaccine.

[51]  Manish M Patel,et al.  Childhood Intussusception: A Literature Review , 2013, PloS one.

[52]  Ian B Hogue,et al.  Virus infections in the nervous system. , 2013, Cell host & microbe.

[53]  John S. Brownstein,et al.  The global distribution and burden of dengue , 2013, Nature.

[54]  Anthony W. Mounts,et al.  Estimating age‐specific cumulative incidence for the 2009 influenza pandemic: a meta‐analysis of A(H1N1)pdm09 serological studies from 19 countries , 2013, Influenza and other respiratory viruses.

[55]  M. Riddle,et al.  Enteric viral infections as potential risk factors for intussusception. , 2013, Journal of infection in developing countries.

[56]  Nicola P Klein,et al.  Safety of quadrivalent human papillomavirus vaccine administered routinely to females. , 2012, Archives of pediatrics & adolescent medicine.

[57]  Manish M Patel,et al.  Removing the Age Restrictions for Rotavirus Vaccination: A Benefit-Risk Modeling Analysis , 2012, PLoS medicine.

[58]  Cornelia L Dekker,et al.  Algorithm to assess causality after individual adverse events following immunizations. , 2012, Vaccine.

[59]  Manish M Patel,et al.  Trends in intussusception hospitalizations among US infants before and after implementation of the rotavirus vaccination program, 2000-2009. , 2012, The Journal of infectious diseases.

[60]  T. Breuer,et al.  Postmarketing Surveillance of Intussusception Following Mass Introduction of the Attenuated Human Rotavirus Vaccine in Mexico , 2012, The Pediatric infectious disease journal.

[61]  T. Vesikari,et al.  Simultaneous presence of human herpesvirus 6 and adenovirus infections in intestinal intussusception of young children , 2012, Acta paediatrica.

[62]  Kazuhiro Nakamura,et al.  Association of viral isolates from stool samples with intussusception in children. , 2011, International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases.

[63]  E. Mignot,et al.  Narcolepsy onset is seasonal and increased following the 2009 H1N1 pandemic in china , 2011, Annals of neurology.

[64]  C P Farrington,et al.  Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice , 2011, Epidemiology and Infection.

[65]  R. Pautler,et al.  Use of Fluoroscopy to Study In Vivo Motility in Mouse Pups , 2011, Journal of pediatric gastroenterology and nutrition.

[66]  H. Kelly,et al.  No-fault compensation following adverse events attributed to vaccination: a review of international programmes. , 2011, Bulletin of the World Health Organization.

[67]  Manish M Patel,et al.  Oral rotavirus vaccines: how well will they work where they are needed most? , 2009, The Journal of infectious diseases.

[68]  W. Ballou.  The development of the RTS,S malaria vaccine candidate: challenges and lessons , 2009, Parasite immunology.

[69]  John P. Mullooly,et al.  Comparison of epidemiologic methods for active surveillance of vaccine safety. , 2008, Vaccine.

[70]  J. Carlin,et al.  Risk factors for intussusception in infants in Vietnam and Australia: adenovirus implicated, but not rotavirus. , 2006, The Journal of pediatrics.

[71]  K. Rothman,et al.  Age dependence of the relation between reassortant rotavirus vaccine (RotaShield) and intussusception. , 2006, The Journal of infectious diseases.

[72]  J. Heyse,et al.  Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. , 2006, The New England journal of medicine.

[73]  Robert J. Taylor,et al.  More on RotaShield and intussusception: the role of age at the time of vaccination. , 2005, The Journal of infectious diseases.

[74]  G. Peter,et al.  Intussusception, rotavirus, and oral vaccines: summary of a workshop. , 2002, Pediatrics.

[75]  A. Elixhauser,et al.  Effect of rotavirus vaccination programme on trends in admission of infants to hospital for intussusception , 2001, The Lancet.

[76]  S. Ellenberg.  Safety considerations for new vaccine development , 2001, Pharmacoepidemiology and drug safety.

[77]  B. Schwartz,et al.  Intussusception among infants given an oral rotavirus vaccine. , 2001, The New England journal of medicine.

[78]  R. Holman,et al.  Lack of an apparent association between intussusception and wild or vaccine rotavirus infection. , 1998, The Pediatric infectious disease journal.

[79]  H. Hsu,et al.  Viral etiology of intussusception in Taiwanese childhood. , 1998, The Pediatric infectious disease journal.

[80]  D. Salmon,et al.  How Vaccine Safety is Monitored , 2016 .

[81]  J. Stockman.  Intussusception Risk and Health Benefits of Rotavirus Vaccination in Mexico and Brazil , 2013 .

[82]  J. Oxford,et al.  Associations between human leukocyte antigens and nonresponsiveness to influenza vaccine. , 2002, The Journal of infectious diseases.

[83]  T. Konno,et al.  Human rotavirus infection in infants and young children with intussusception , 1978, Journal of medical virology.