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Vaccine adverse events

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https://www.readbyqxmd.com/read/28086819/efficacy-safety-and-effectiveness-of-licensed-rotavirus-vaccines-a-systematic-review-and-meta-analysis-for-latin-america-and-the-caribbean
#1
Raúl F Velázquez, Alexandre C Linhares, Sergio Muñoz, Pamela Seron, Pedro Lorca, Rodrigo DeAntonio, Eduardo Ortega-Barria
BACKGROUND: RotaTeq™ (RV5; Merck & Co. Inc., USA) and Rotarix™ (RV1, GlaxoSmithKline, Belgium) vaccines, developed to prevent rotavirus diarrhea in children under five years old, were both introduced into national immunization programs in 2006. As many countries in Latin America and the Caribbean have included either RV5 or RV1 in their routine childhood vaccination programs, we conducted a systematic review and meta-analysis to analyze efficacy, safety and effectiveness data from the region...
January 13, 2017: BMC Pediatrics
https://www.readbyqxmd.com/read/28081133/the-power-of-malaria-vaccine-trials-using-controlled-human-malaria-infection
#2
Luc E Coffeng, Cornelus C Hermsen, Robert W Sauerwein, Sake J de Vlas
Controlled human malaria infection (CHMI) in healthy human volunteers is an important and powerful tool in clinical malaria vaccine development. However, power calculations are essential to obtain meaningful estimates of protective efficacy, while minimizing the risk of adverse events. To optimize power calculations for CHMI-based malaria vaccine trials, we developed a novel non-linear statistical model for parasite kinetics as measured by qPCR, using data from mosquito-based CHMI experiments in 57 individuals...
January 2017: PLoS Computational Biology
https://www.readbyqxmd.com/read/28079828/vaccination-with-10-valent-pneumococcal-conjugate-vaccine-in-infants-according-to-hiv-status
#3
Shabir A Madhi, Anthonet Koen, Lisa Jose, Nadia van Niekerk, Peter V Adrian, Clare Cutland, Nancy François, Javier Ruiz-Guiñazú, Juan-Pablo Yarzabal, Marta Moreira, Dorota Borys, Lode Schuerman
BACKGROUND: Phase III, open-label, single-center, controlled study in South Africa (ClinicalTrials.gov: NCT00829010) to evaluate immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) children. METHODS: Children stratified by HIV status received PHiD-CV primary vaccination (age 6/10/14 weeks; coadministered with routine childhood vaccines) and booster dose (age 9-10 months)...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28077730/effect-of-an-early-dose-of-measles-vaccine-on-morbidity-between-18-weeks-and-9-months-of-age-a-randomized-controlled-trial-in-guinea-bissau
#4
Vu An Do, Sofie Biering-Sørensen, Ane Bærent Fisker, Carlito Balé, Stine Møller Rasmussen, Lone Damkjær Christensen, Kristoffer Jarlov Jensen, Cesário Martins, Peter Aaby, Christine Stabell Benn
BACKGROUND:  Children in Guinea-Bissau receive measles vaccine (MV) at 9 months of age, but studies have shown that an additional dose before 9 months of age might have beneficial nonspecific effects. Within a randomized trial designed to examine nonspecific effects of early MV receipt on mortality, we conducted a substudy to investigate the effect of early MV receipt on morbidity. METHODS:  Children were randomly assigned at a ratio of 2:1 to receive 2 doses of MV at 18 weeks and age 9 months (intervention group) or 1 dose of MV at age 9 months, in accordance with current practice (control group)...
January 10, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28077584/2-year-efficacy-immunogenicity-and-safety-of-vigoo-enterovirus-71-vaccine-in-healthy-chinese-children-a-randomized-open-label-study
#5
Mingwei Wei, Fanyue Meng, Shiyuan Wang, Jingxin Li, Yuntao Zhang, Qunying Mao, Yuemei Hu, Pei Liu, Nianmin Shi, Hong Tao, Kai Chu, Yuxiao Wang, Zhenglun Liang, Xiuling Li, Fengcai Zhu
BACKGROUND:  This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine. METHOD:  In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years...
January 1, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28073858/boosting-immune-responses-following-fractional-dose-inactivated-poliovirus-vaccine-a-randomized-controlled-trial
#6
Sonia Resik, Alina Tejeda, Manuel Diaz, Hiromasa Okayasu, Carolyn Sein, Natalie A Molodecky, Magile Fonseca, Nilda Alemany, Gloria Garcia, Lai Heng Hung, Yenisleydis Martinez, Roland W Sutter
BACKGROUND:  Fractional-dose administration of inactivated poliovirus vaccine (fIPV) could increase IPV affordability and stretch limited supplies. We assessed immune responses following fIPV administered intradermally, compared with full-dose IPV administered intramuscularly, among adults with a history of oral poliovirus vaccine (OPV) receipt. METHODS:  We conducted a randomized, controlled noninferiority trial in Cuba. fIPV or IPV were administered on days 0 and 28; serum was collected on days 0, 7, 28, and 56 for analysis by a neutralization assay...
January 9, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28072958/-investigation-on-immunization-program-coverage-rate-and-its-safety-in-children-with-tuberous-sclerosis
#7
Y Gao, L P Zou, M N Zhang, L Y Pang, Y Y Wang, S F Ma, L L Huang
Objective: To investigate the status of immunization of National Immunization Program (NIP) and its adverse reaction rate in children with tuberous sclerosis. Method: Questionnaire survey was adopted to identify the vaccination coverage and its adverse events; 72 cases of children with tuberous sclerosis and 78 normal controls (healthy children completing age-appropriate NIP) admitted to Chinese People's Liberation Army General Hospital from December 2014 to November 2015 were involved into this study. Result: The age-appropriate NIP coverage rate of tuberous sclerosis was 36%(26/72)...
January 2, 2017: Zhonghua Er Ke za Zhi. Chinese Journal of Pediatrics
https://www.readbyqxmd.com/read/28068680/-rare-adverse-events-following-immunization-coincidence
#8
Gian Loreto D'Alò, Elisa Terracciano, Ermanno Zorzoli, Alessandra Capanna, Giuseppe Gervasi, Laura Zaratti, Elisabetta Franco
The high standards of safety and effectiveness of vaccines have allowed them to get a prominent role in disease prevention and health protection. However, like any other intervention, vaccination is not free from risks. Rare adverse events occur after immunization in less than one in a thousand individuals and can be linked to vaccination by causality or coincidence. These events are reported on the SmPC (Summary of Product Characteristics). We have first divided the rare adverse events in local and generalized, and then we have analyzed them according to the type of vaccine linked to the event...
September 2016: Igiene e Sanità Pubblica
https://www.readbyqxmd.com/read/28068212/immunogenicity-and-safety-of-an-adjuvanted-herpes-zoster-subunit-candidate-vaccine-in-adults-%C3%A2-50%C3%A2-years-of-age-with-a-prior-history-of-herpes-zoster-a-phase-iii-non-randomized-open-label-clinical-trial
#9
Olivier Godeaux, Martina Kovac, Daniel Shu, Katrijn Grupping, Laura Campora, Martine Douha, Thomas C Heineman, Himal Lal
This phase III, non-randomized, open-label, multi-center study (NCT01827839) evaluated the immunogenicity and safety of an adjuvanted recombinant subunit herpes zoster (HZ) vaccine (HZ/su) in adults aged ≥50 years with prior physician-documented history of HZ. Participants (stratified by age: 50-59, 60-69 and ≥70 years) received 2 doses of HZ/su 2 months apart and were followed-up for another 12 months. Anti-glycoprotein E (gE) antibodies were measured by enzyme-linked immunosorbent assay before vaccination and 1 month after the second dose (Month 3)...
January 9, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28062552/time-to-change-dosing-of-inactivated-quadrivalent-influenza-vaccine-in-young-children-evidence-from-a-phase-iii-randomized-controlled-trial
#10
Varsha K Jain, Joseph B Domachowske, Long Wang, Opokua Ofori-Anyinam, Miguel A Rodríguez-Weber, Michael L Leonardi, Nicola P Klein, Gary Schlichter, Robert Jeanfreau, Byron L Haney, Laurence Chu, Jo-Ann S Harris, Kwabena O Sarpong, Amanda C Micucio, Jyoti Soni, Vijayalakshmi Chandrasekaran, Ping Li, Bruce L Innis
BACKGROUND: Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose. METHODS: We compared the only United States-licensed standard-dose IIV4 (0.25 mL, 7.5 µg hemagglutinin per influenza strain) versus double-dose IIV4 manufactured by a different process (0.5 mL, 15 µg per strain) in a phase III, randomized, observer-blind trial in children 6-35 months of age (NCT02242643). The primary objective was to demonstrate immunogenic noninferiority of the double-dose for all vaccine strains 28 days after last vaccination...
January 6, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/28060048/a-randomized-controlled-trial-to-evaluate-a-potential-hepatitis-b-booster-vaccination-strategy-using-combined-hepatitis-a-and-b-vaccine
#11
Fangjun Li, Yuansheng Hu, Youming Zhou, Lixin Chen, Wei Xia, Yufei Song, Zhengliang Tan, Lidong Gao, Zhong Yang, Gang Zeng, Xing Han
BACKGROUND: Booster doses could play a major role in those no responders or low responders to primary hepatitis B vaccine. Planed time point for hepatitis A vaccination in China provides a good opportunity to carry out hepatitis B booster dose by using combined hepatitis A and B vaccine. METHOD: A randomized, double blinded clinical trial was conducted to compare the immunogenicity and safety of toddlers 18-24 months of age receiving three different vaccination regimens: either two doses of inactivated hepatitis A vaccine (group 1), or one dose inactivated hepatitis A vaccine plus one dose combined hepatitis A and B vaccine (group 2), or two doses of combined hepatitis A and B vaccine (group 3) respectively...
January 3, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28045585/immunogenicity-and-safety-of-purified-vero-cell-rabies-vaccine-pvrv-under-zagreb-2-1-1-or-5-dose-essen-regimen-in-chinese-adults-aged-50-and-above
#12
Jing Wang, FengJi Luo, ZiJian Feng, Li Li, YunHua Bai, Xing Ai, JianXin Ma, Zheng Zhang, NianMin Shi
BACKGROUND: Two kinds of regimens (2-1-1 and 1-1-1-1-1) can be selected after Zagreb regimen(2-1-1)of PVRV was officially approved in Beijing in January 2015. Up to now, the subjects for most studies about the comparison between Zagreb and Essen regimen are under 50 years old, rarely at and above. Aging of the immune system may result in decreasing efficacy of vaccination, especially for adults aged above 65-70 years. This study compared the safety and immunogenicity of the Zagreb and Essen regimen in Chinese adults aged 50 and above with the goal to provide a supplemental data for this age group...
January 3, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28043221/adverse-events-following-immunisation-with-bacille-calmette-gu%C3%A3-rin-vaccination-baseline-data-to-inform-monitoring-in-australia-following-introduction-of-new-unregistered-bcg-vaccine
#13
Alexandra J Hendry, Aditi Dey, Frank H Beard, Gulam Khandaker, Richard Hill, Kristine K Macartney
In recent years there has been a global shortage of bacille Calmette-Guérin (BCG) vaccine and, from September 2012, unregistered vaccines have needed to be used in Australia (a Danish product initially until the end of 2015, and a Polish product used in some jurisdictions from early 2016). We examined rates and types of adverse events following immunisation (AEFI) with BCG vaccine reported to the Therapeutic Goods Administration between 2009 and 2014 in children aged less than 7 years. Reporting rates of AEFI with BCG vaccine increased from 87 per 100,000 doses (registered Sanofi Pasteur product) in 2009 to 201 per 100,000 doses (unregistered Danish Statens Serum Institute product) in 2014, with Victoria having the highest rate each year...
December 24, 2016: Communicable Diseases Intelligence Quarterly Report
https://www.readbyqxmd.com/read/28042137/immunogenicity-and-safety-of-human-papillomavirus-hpv-vaccination-in-asian-populations-from-six-countries-a-meta-analysis
#14
Didik Setiawan, Jos Luttjeboer, Koen B Pouwels, Jan C Wilschut, Maarten J Postma
Cervical cancer is a serious public-health problem in Asian countries. Since human papillomavirus (HPV) infection is the main risk factor for cervical cancer, HPV vaccination is considered a promising strategy to prevent cervical cancer. However, comprehensive immunogenicity and safety information for Asian populations is lacking. We searched four electronic databases including PubMed, EMBASE, Cochrane Library, and clinicaltrials.gov. We reviewed selected manuscripts and extracted the pooled relative risk (RR) from immunogenicity and safety information on HPV vaccination among women in Asian countries...
January 1, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28031551/a-two-phase-case-control-study-of-autism-risk-among-children-born-from-the-late-1990s-through-the-early-2000s-in-the-united-states
#15
David A Geier, Janet K Kern, Mark R Geier
BACKGROUND This study evaluated the hypothesis that the 1999 recommendation by the American Academy of Pediatrics (AAP) and US Public Health Service (PHS) to reduce exposure to mercury (Hg) from Thimerosal in US vaccines would be associated with a reduction in the long-term risk of being diagnosed with autism. MATERIAL AND METHODS A two-phase assessment utilizing a case (n=73) -control (n=11,783) study in the Vaccine Adverse Event Reporting System (VAERS) database (for hypothesis generating) and a more rigorous, independent matched case (n=40) -control (n=40) study (hypothesis testing) was undertaken...
December 29, 2016: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/28030521/immunogenicity-and-safety-of-10-valent-pneumococcal-non-typeable-haemophilus-influenzae-protein-d-conjugate-vaccine-phid-cv-administered-to-children-with-sickle-cell-disease-between-8-weeks-and-2-years-of-age-a-phase-iii-open-controlled-study
#16
Sodiomon B Sirima, Alfred Tiono, Zakaria Gansané, Mohamadou Siribié, Angèle Zongo, Alphonse Ouédraogo, Nancy François, Ana Strezova, Kurt Dobbelaere, Dorota Borys
BACKGROUND: Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in children with sickle cell disease (SCD), who are at increased risk for infections. METHODS: In this phase III, open-label, single center, controlled study in Burkina Faso (NCT01175083), children with SCD (S) or without SCD (NS) were assigned to 6 groups (N=300): children 8-11 weeks of age (<6 months; <6S and <6NS groups) received 3 primary doses and a booster dose of PHiD-CV co-administered with routine childhood vaccines; children 7-11 months of age (7-11S and 7-11NS groups) received 2 primary doses and a booster dose of PHiD-CV; children 12-23 months of age (12-23S and 12-23NS groups) received 2 catch-up doses of PHiD-CV...
December 27, 2016: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28017403/efficacy-and-effectiveness-of-an-rvsv-vectored-vaccine-in-preventing-ebola-virus-disease-final-results-from-the-guinea-ring-vaccination-open-label-cluster-randomised-trial-ebola-%C3%A3-a-suffit
#17
Ana Maria Henao-Restrepo, Anton Camacho, Ira M Longini, Conall H Watson, W John Edmunds, Matthias Egger, Miles W Carroll, Natalie E Dean, Ibrahima Diatta, Moussa Doumbia, Bertrand Draguez, Sophie Duraffour, Godwin Enwere, Rebecca Grais, Stephan Gunther, Pierre-Stéphane Gsell, Stefanie Hossmann, Sara Viksmoen Watle, Mandy Kader Kondé, Sakoba Kéïta, Souleymane Kone, Eewa Kuisma, Myron M Levine, Sema Mandal, Thomas Mauget, Gunnstein Norheim, Ximena Riveros, Aboubacar Soumah, Sven Trelle, Andrea S Vicari, John-Arne Røttingen, Marie-Paule Kieny
BACKGROUND: rVSV-ZEBOV is a recombinant, replication competent vesicular stomatitis virus-based candidate vaccine expressing a surface glycoprotein of Zaire Ebolavirus. We tested the effect of rVSV-ZEBOV in preventing Ebola virus disease in contacts and contacts of contacts of recently confirmed cases in Guinea, west Africa. METHODS: We did an open-label, cluster-randomised ring vaccination trial (Ebola ça Suffit!) in the communities of Conakry and eight surrounding prefectures in the Basse-Guinée region of Guinea, and in Tomkolili and Bombali in Sierra Leone...
December 23, 2016: Lancet
https://www.readbyqxmd.com/read/28017399/safety-and-immunogenicity-of-a-recombinant-adenovirus-type-5-vector-based-ebola-vaccine-in-healthy-adults-in-sierra-leone-a-single-centre-randomised-double-blind-placebo-controlled-phase-2-trial
#18
Feng-Cai Zhu, Alie H Wurie, Li-Hua Hou, Qi Liang, Yu-Hua Li, James B W Russell, Shi-Po Wu, Jing-Xin Li, Yue-Mei Hu, Qiang Guo, Wen-Bo Xu, Abdul R Wurie, Wen-Juan Wang, Zhe Zhang, Wen-Jiao Yin, Manal Ghazzawi, Xu Zhang, Lei Duan, Jun-Zhi Wang, Wei Chen
BACKGROUND: A recombinant adenovirus type-5 vector-based vaccine expressing the glycoprotein of Ebola Zaire Makona variant showed good safety and immunogenicity in a phase 1 trial of healthy Chinese adults. We aimed to assess the safety and immunogenicity of this vaccine in healthy adults in Sierra Leone and to determine the optimal dose. METHODS: We did a single-centre, randomised, double-blind, placebo-controlled, phase 2 clinical trial at Sierra Leone-China Friendship Hospital, Freetown, Sierra Leone...
December 22, 2016: Lancet
https://www.readbyqxmd.com/read/28010246/safety-and-immunogenicity-of-a-recombinant-staphylococcus-aureus-%C3%AE-toxoid-and-a-recombinant-panton-valentine-leukocidin-subunit-in-healthy-adults
#19
Michael L Landrum, Tahaniyat Lalani, Minoo Niknian, Jason D Maguire, Duane R Hospenthal, Ali Fattom, Kimberly Taylor, Jamie Fraser, Kenneth Wilkins, Michael W Ellis, Paul D Kessler, Rafaat E F Fahim, David R Tribble
We conducted a randomized, double-blind, placebo-controlled dose-escalation study in healthy adults to evaluate the safety and immunogenicity of recombinant Staphylococcus aureus candidate vaccine antigens, recombinant α-toxoid (rAT) and a sub-unit of Panton-Valentine leukocidin (rLukS-PV). 176 subjects were enrolled and randomized within 1 of 11 treatment cohorts: monovalent rAT or rLukS-PV dosages of 10, 25, 50, and 100 μg; bivalent rAT:rLukS dosages of 10:10, 25:25, and 50:50 μg; and alum or saline placebo...
December 23, 2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28007050/an-adverse-drug-event-manager-facilitates-spontaneous-reporting-of-adverse-drug-reactions
#20
Siri Vinther, Pia Klarskov, Hanne Borgeskov, Perle Darsø, Anette Kvindebjerg Christophersen, Bille Borck, Catrine Christensen, Melissa Voigt Hansen, Natalie Monica Løvland Halladin, Mikkel Bring Christensen, Kirstine Moll Harboe, Marie Lund, Espen Jimenez-Solem
INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014...
January 2017: Danish Medical Journal
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