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The 13-valent pneumococcal conjugate vaccine for invasive pneumococcal disease in Alaska native children: results of a clinical trial.

https://arctichealth.org/en/permalink/ahliterature120452
Source
Pediatr Infect Dis J. 2013 Mar;32(3):257-63
Publication Type
Article
Date
Mar-2013

Applicability of the Brighton Collaboration Case Definition for seizure after immunization in active and passive surveillance in Canada.

https://arctichealth.org/en/permalink/ahliterature106841
Source
Vaccine. 2013 Nov 19;31(48):5700-5
Publication Type
Article
Date
Nov-19-2013
Author
Karina A Top
Cora M Constantinescu
Julie Laflèche
Julie A Bettinger
David W Scheifele
Wendy Vaudry
Scott A Halperin
Barbara J Law
Author Affiliation
Department of Pediatrics, Dalhousie University and Canadian Center for Vaccinology, IWK Health Centre, 5850/5980 University Avenue, Halifax, NS, Canada B3K 6R8; Mailman School of Public Health, Columbia University Medical Center, 722 West 168th Street, New York, NY 10032, USA. Electronic address: karina.top@dal.ca.
Source
Vaccine. 2013 Nov 19;31(48):5700-5
Date
Nov-19-2013
Language
English
Publication Type
Article
Keywords
Canada - epidemiology
Drug-Related Side Effects and Adverse Reactions - epidemiology - pathology
Epidemiological Monitoring
Female
Humans
Infant
Infant, Newborn
Male
Retrospective Studies
Seizures - chemically induced - pathology
Vaccination - adverse effects
Vaccines - administration & dosage - adverse effects
Abstract
The Canadian Adverse Event Following Immunization Surveillance System (CAEFISS) receives reports via active syndromic surveillance for selected serious AEFI from the Canadian Immunization Monitoring Program Active (IMPACT) and via targeted passive surveillance from Federal/Provincial/Territorial health jurisdictions. Post-immunization seizure is a target of active and passive surveillance. Since 2009, the revised national AEFI reporting forms enable capture of terms specific to several Brighton Collaboration Case Definitions (BCCD) including generalized seizure and fever.
To evaluate feasibility of applying the BCCD for generalized seizure to adverse event following immunization (AEFI) reports collected by IMPACT and targeted passive surveillance (non-IMPACT).
Reports to CAEFISS coded as seizure in children
PubMed ID
24099871 View in PubMed
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Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is associated with pandemic influenza infection, but not with an adjuvanted pandemic influenza vaccine.

https://arctichealth.org/en/permalink/ahliterature275416
Source
Vaccine. 2015 Nov 17;33(46):6173-7
Publication Type
Article
Date
Nov-17-2015
Author
Per Magnus
Nina Gunnes
Kari Tveito
Inger Johanne Bakken
Sara Ghaderi
Camilla Stoltenberg
Mady Hornig
W Ian Lipkin
Lill Trogstad
Siri E Håberg
Source
Vaccine. 2015 Nov 17;33(46):6173-7
Date
Nov-17-2015
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Aged, 80 and over
Child
Child, Preschool
Cohort Studies
Drug-Related Side Effects and Adverse Reactions - epidemiology - pathology
Fatigue Syndrome, Chronic - epidemiology
Female
Humans
Incidence
Infant
Infant, Newborn
Influenza Vaccines - administration & dosage - adverse effects
Influenza, Human - complications
Male
Middle Aged
Norway - epidemiology
Risk assessment
Young Adult
Abstract
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is associated to infections and it has been suggested that vaccination can trigger the disease. However, little is known about the specific association between clinically manifest influenza/influenza vaccine and CFS/ME. As part of a registry surveillance of adverse effects after mass vaccination in Norway during the 2009 influenza A (H1N1) pandemic, we had the opportunity to estimate and contrast the risk of CFS/ME after infection and vaccination.
Using the unique personal identification number assigned to everybody who is registered as resident in Norway, we followed the complete Norwegian population as of October 1, 2009, through national registries of vaccination, communicable diseases, primary health, and specialist health care until December 31, 2012. Hazard ratios (HRs) of CFS/ME, as diagnosed in the specialist health care services (diagnostic code G93.3 in the International Classification of Diseases, Version 10), after influenza infection and/or vaccination were estimated using Cox proportional-hazards regression.
The incidence rate of CFS/ME was 2.08 per 100,000 person-months at risk. The adjusted HR of CFS/ME after pandemic vaccination was 0.97 (95% confidence interval [CI]: 0.91-1.04), while it was 2.04 (95% CI: 1.78-2.33) after being diagnosed with influenza infection during the peak pandemic period.
Pandemic influenza A (H1N1) infection was associated with a more than two-fold increased risk of CFS/ME. We found no indication of increased risk of CFS/ME after vaccination. Our findings are consistent with a model whereby symptomatic infection, rather than antigenic stimulation may trigger CFS/ME.
PubMed ID
26475444 View in PubMed
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Increased reactions to pediatric influenza vaccination following concomitant pneumococcal vaccination.

https://arctichealth.org/en/permalink/ahliterature125266
Source
Influenza Other Respir Viruses. 2013 Mar;7(2):184-90
Publication Type
Article
Date
Mar-2013

Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1pdm09) vaccine.

https://arctichealth.org/en/permalink/ahliterature106576
Source
Vaccine. 2013 Dec 5;31(50):5989-96
Publication Type
Article
Date
Dec-5-2013

Safety and immunogenicity of 2010–2011 A/H1N1pdm09-containing trivalent inactivated influenza vaccine in adults previously given AS03-adjuvanted H1N1 2009 pandemic vaccine: results of a randomized trial.

https://arctichealth.org/en/permalink/ahliterature114880
Source
Hum Vaccin Immunother. 2013 Jan;9(1):136-43
Publication Type
Article
Date
Jan-2013
Author
David W Scheifele
Marc Dionne
Brian J Ward
Curtis Cooper
Otto G Vanderkooi
Yan Li
Scott A Halperin
Author Affiliation
Vaccine Evaluation Center, BC Children’s Hospital, University of British Columbia, Vancouver, BC Canada. dscheifele@cfri.ca
Source
Hum Vaccin Immunother. 2013 Jan;9(1):136-43
Date
Jan-2013
Language
English
Publication Type
Article
Keywords
Adult
Antibodies, Viral - blood
Canada
Cross-Over Studies
Drug-Related Side Effects and Adverse Reactions - epidemiology - pathology
Female
Humans
Immunization, Secondary - adverse effects - methods
Influenza A Virus, H1N1 Subtype - immunology
Influenza Vaccines - administration & dosage - adverse effects - immunology
Middle Aged
Placebos - administration & dosage
Vaccines, Inactivated - administration & dosage - adverse effects - immunology
Abstract
Many Canadians received a novel AS03-adjuvanted vaccine during the 2009 influenza A/H1N1 pandemic. Longer term implications of adjuvant use were unclear: would anti-H1N1 immune responses persist at high levels and, if so, could that result in increased or unusual adverse effects upon re-exposure to H1N1pdm09 antigen in the trivalent influenza vaccine (TIV) for 2010-11? To answer these questions, adults given AS03-adjuvanted H1N1pdm09 vaccine (Arepanrix®, GSK Canada) 9-10 mo earlier were enrolled in an evaluator-blinded, crossover trial to receive 2010-2011 non-adjuvanted TIV (Fluviral®, GSK Canada) and placebo 10 d apart, in random order. Adverse effects were monitored for 7 d after each injection. Vaccine-attributable adverse event (VAAE) rates were calculated by subtracting rates after placebo from those after vaccine. Blood was obtained pre-vaccination and 21-30 d afterward to measure hemagglutination inhibiting antibody titers. In total, 326 participants were enrolled and 321 completed the study. VAAE rates were low except for myalgia (18.6%) and injection site pain (63.2%). At baseline, H1N1pdm09 titers = 40 were present in 176/325 subjects (54.2%, 95% confidence interval 48.6, 59.7), with a geometric mean titer (GMT) of 37.4 (95% CI 32.8, 42.6). Post-immunization, 96.0% (95% CI 92.3, 97.8) had H1N1pdm09 titers = 40, with GMT of 167.4 (95% CI 148.7, 188.5). Responses to both influenza A strains in TIV were similar, implying no lasting effect of adjuvant exposure. In summary, titers = 40 persisted in only half the participants 9-10 mo after adjuvanted pandemic vaccine but were restored in nearly all after TIV vaccination, with minimal increase in adverse effects.
Notes
Cites: Pharmacoepidemiol Drug Saf. 2002 Apr-May;11(3):189-20212051118
Cites: Clin Infect Dis. 2003 Mar 15;36(6):705-1312627354
Cites: Clin Infect Dis. 2003 Apr 1;36(7):850-712652385
Cites: Vaccine. 2003 Jun 2;21(19-20):2354-6112744866
Cites: Dev Biol (Basel). 2003;115:9-1615088770
Cites: J Infect Dis. 1981 Oct;144(4):3767288216
Cites: Vaccine. 2005 May 25;23(28):3726-3215882534
Cites: Infect Immun. 2005 Dec;73(12):8130-516299307
Cites: Pediatr Infect Dis J. 2009 Nov;28(11):985-919755930
Cites: Vaccine. 2010 Feb 17;28(7):1740-520034605
Cites: Wkly Epidemiol Rec. 2010 Mar 5;85(10):81-9220210260
Cites: BMC Infect Dis. 2010;10:7120236548
Cites: Vaccine. 2010 Jul 12;28(31):4895-90220553769
Cites: Vaccine. 2011 Aug 5;29(34):5785-9221624411
Cites: Clin Vaccine Immunol. 2011 Sep;18(9):1401-521795459
Cites: CMAJ. 2011 Sep 20;183(13):E1033-721788422
Cites: Vaccine. 2011 Dec 9;30(1):35-4122063386
Cites: Clin Trials. 2011 Dec;8(6):699-70421900340
Cites: J Infect Dis. 2012 Mar 1;205(5):733-4422315336
Cites: Clin Infect Dis. 2012 Mar 1;54(5):661-922267719
Cites: Vaccine. 2012 May 14;30(23):3389-9422469860
Cites: Vaccine. 2012 Jul 6;30(32):4728-3222652402
Cites: Can Commun Dis Rep. 2001 May 15;27(10):85-9011396047
PubMed ID
23570051 View in PubMed
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Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects.

https://arctichealth.org/en/permalink/ahliterature286585
Source
Hum Vaccin Immunother. 2016 Aug 02;12(8):2142-2147
Publication Type
Article
Date
Aug-02-2016
Author
Karen Ciprero
Kirill A Zykov
Nikolay I Briko
Tulin Shekar
Tina M Sterling
Elizaveta Bitieva
Jon E Stek
Luwy Musey
Source
Hum Vaccin Immunother. 2016 Aug 02;12(8):2142-2147
Date
Aug-02-2016
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Bacterial - blood
Child
Child, Preschool
Drug-Related Side Effects and Adverse Reactions - epidemiology - pathology
Female
Humans
Immunoglobulin G - blood
Injections, Intramuscular
Male
Middle Aged
Pneumococcal Vaccines - administration & dosage - adverse effects - immunology
Russia
Young Adult
Abstract
Pneumococcal infection is a major cause of pneumonia, bacteremia, and meningitis. Incidence of pneumococcal disease (PD) varies worldwide. The 23-valent pneumococcal polysaccharide vaccine (PPV23) displays an acceptable safety profile and has been demonstrated cost-effective in reducing burden of PD.
Approximately 100 subjects from the Russian Federation who were either 2 to 49 y of age with increased risk for PD or =50 years of age were enrolled into the study (NCT01734239) to receive a single dose of PPV23 administered intramuscularly. Each subject was followed for local and systemic adverse events (AEs) for 5 and 14 days, respectively. Serious AEs were collected for 28 d postvaccination. Blood samples were collected immediately prior to vaccination and 28 d postvaccination for the measurement of IgG to serotypes 1, 6B, 14, 19F, and 23F.
High proportion of subjects had =2 -fold increase in IgG following receipt of PPV23. Rates were 92.0%, 83.0%, 89.0%, 81%, 84% for serotypes 1, 6B, 14, 19F, and 23F, respectively. Similar rates of responders and increases in the magnitude of immune responses were observed in both age groups (2-49, =50 ). PPV23 was generally safe and well tolerated. Injection site and systemic AEs were reported by 14.7% and 18.6% of study subjects, respectively.
PPV23 is generally safe, well tolerated, and highly immunogenic when given as a single dose to Russian individuals 50 y of age and older, as well as Russian individuals 2 to 49 y of age who are at high risk for PD.
Notes
Cites: Hum Vaccin. 2009 Sep;5(9):608-1319617717
Cites: Expert Rev Vaccines. 2015 Jul;14(7):975-103026083459
Cites: J Infect Dis. 2010 Feb 15;201(4):525-3320088694
Cites: BMJ. 2010 Mar 08;340:c100420211953
Cites: Infection. 2015 Dec;43(6):699-70626037386
Cites: N Engl J Med. 1991 Nov 21;325(21):1453-601944423
Cites: Lancet. 1998 Feb 7;351(9100):399-4039482293
Cites: Clin Infect Dis. 2014 Apr;58(7):909-1724532544
Cites: JAMA. 2001 Apr 4;285(13):1729-3511277827
Cites: N Engl J Med. 2003 May 1;348(18):1747-5512724480
Cites: J Infect Dis. 2010 Jan 1;201(1):32-4119947881
Cites: Clin Infect Dis. 2005 Jun 1;40(11):1608-1615889358
Cites: Voen Med Zh. 2004 Dec;325(12):35-43, 9615690855
Cites: JAMA. 1977 Dec 12;238(24):2613-621973
Cites: Vaccine. 2010 Jul 12;28(31):4955-6020576535
Cites: Hum Vaccin. 2011 Sep;7(9):919-2821860256
Cites: Clin Infect Dis. 2014 Oct 15;59(8):1168-7625038114
Cites: J Infect Dis. 1983 Dec;148(6):1136-596361173
Cites: Clin Vaccine Immunol. 2006 Aug;13(8):905-1216893991
Cites: Vaccine. 2009 Mar 4;27(10):1504-1019171174
Cites: Expert Rev Vaccines. 2014 Feb;13(2):257-6424350587
Cites: Cochrane Database Syst Rev. 2008 Jan 23;(1):CD00042218253977
Cites: CMAJ. 2009 Jan 6;180(1):48-5819124790
Cites: Clin Microbiol Rev. 2003 Apr;16(2):308-1812692100
Cites: Lancet. 2009 Sep 12;374(9693):893-90219748398
Cites: Thorax. 2015 Oct;70(10):984-926219979
Cites: J Infect Dis. 2005 Aug 1;192(3):377-8615995950
PubMed ID
27149114 View in PubMed
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Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years: Interim analysis of a large community-randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature285993
Source
Hum Vaccin Immunother. 2016 Dec;12(12):3177-3185
Publication Type
Article
Date
Dec-2016
Author
Matti Lehtinen
Tiina Eriksson
Dan Apter
Mari Hokkanen
Kari Natunen
Jorma Paavonen
Eero Pukkala
Maria-Genalin Angelo
Julia Zima
Marie-Pierre David
Sanjoy Datta
Dan Bi
Frank Struyf
Gary Dubin
Source
Hum Vaccin Immunother. 2016 Dec;12(12):3177-3185
Date
Dec-2016
Language
English
Publication Type
Article
Keywords
Adolescent
Aluminum Hydroxide - administration & dosage - adverse effects
Autoimmune Diseases - chemically induced - epidemiology
Child
Drug-Related Side Effects and Adverse Reactions - epidemiology - pathology
Female
Finland
Hepatitis B Vaccines - administration & dosage - adverse effects
Humans
Lipid A - administration & dosage - adverse effects - analogs & derivatives
Male
Papillomavirus Infections - prevention & control
Papillomavirus Vaccines - administration & dosage - adverse effects
Abstract
This community-randomized controlled trial was initiated to assess the overall and herd effects of 2 different human papillomavirus (HPV) immunization strategies in over 80,000 girls and boys aged 12-15?y in 33 communities in Finland (ClinicalTrials.gov NCT00534638). Overall, 14,838 adolescents received HPV-16/18 vaccine (2,440 boys and 12,398 girls) and 17,338 received hepatitis-B virus (HBV) vaccine (9,221 boys and 8,117 girls). In an interim analysis, vaccine safety was assessed by active monitoring and surveillance via health registry linkage. Active monitoring showed that the HPV-16/18 vaccine has acceptable safety and reactogenicity in boys. In all study participants, the observed incidences (per 100,000 person-years) of serious adverse events (SAEs) possibly related to vaccination were 54.3 (95% Confidence Interval [CI]: 34.0-82.1) in the HPV-16/18 group and 64.0 (95% CI: 43.2-91.3) in the HBV group. During the follow-up period for this interim analysis, the most common new-onset autoimmune diseases (NOADs; with incidence rate =15 per 100,000) in any group based on hospital discharge registry (HILMO) download were ulcerative colitis, juvenile arthritis, celiac disease, insulin-dependent diabetes mellitus (IDDM) and Crohn's disease. No increased NOAD incidences were observed in HPV-16/18 vaccine recipients compared to HBV vaccine recipients. In both the SAE possibly related- and HILMO-analyses, a lower incidence of IDDM was observed in HPV-16/18 vaccinees compared to HBV vaccinees (relative risks, 0.26 [95% CI: 0.03-1.24] and 0.16 [95% CI: 0.03-0.55], respectively).
Notes
Cites: Nat Rev Clin Oncol. 2013 Jul;10(7):400-1023736648
Cites: Vaccine. 2015 Nov 27;33(48):6884-9126206268
Cites: BMJ. 2013 Oct 09;347:f590624108159
Cites: J Adolesc Health. 2010 May;46(5):414-2120413076
Cites: Lancet. 2011 Jun 18;377(9783):2085-9221684381
Cites: Curr Opin Obstet Gynecol. 2015 Aug;27(4):265-7026125978
Cites: Vaccine. 2008 Dec 2;26(51):6630-818845199
Cites: Vaccine. 2006 Aug 31;24 Suppl 3:S3/233-4116950012
Cites: BMJ. 2015 Sep 07;351:h435826346155
Cites: J Intern Med. 2012 Feb;271(2):193-20321973261
Cites: Vaccine. 2015 Mar 3;33(10):1284-9025593103
Cites: MMWR Morb Mortal Wkly Rep. 2015 Mar 27;64(11):300-425811679
Cites: Pharmacoepidemiol Drug Saf. 2014 May;23(5):456-6524644078
Cites: J Adolesc Health. 2012 Feb;50(2):187-9422265115
Cites: Int J Cancer. 2013 Jun 15;132(12):2833-823180157
Cites: Vaccine. 2012 Nov 20;30 Suppl 5:F139-4823199957
Cites: BMJ. 2010 Mar 02;340:c71220197322
Cites: Vaccine. 2011 Nov 15;29(49):9276-8321856349
Cites: Lancet Infect Dis. 2012 Oct;12(10):781-922920953
Cites: Lancet. 2008 May 24;371(9626):1777-8218502302
Cites: J Adolesc Health. 2009 Jan;44(1):33-4019101456
Cites: Pharmacoepidemiol Drug Saf. 2014 May;23(5):466-7924644063
Cites: Lancet Oncol. 2012 Jan;13(1):100-1022075170
Cites: Lancet Oncol. 2015 May;16(5):e206-1625943065
Cites: N Engl J Med. 2007 May 10;356(19):1915-2717494925
Cites: Lancet. 2007 Jun 30;369(9580):2161-7017602732
Cites: Hum Vaccin. 2009 May;5(5):332-4019221517
Cites: BioDrugs. 2011 Aug 1;25(4):217-2621815697
Cites: MMWR Recomm Rep. 2007 Mar 23;56(RR-2):1-2417380109
PubMed ID
27841725 View in PubMed
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Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years.

https://arctichealth.org/en/permalink/ahliterature271149
Source
Vaccine. 2015 Jul 17;33(31):3717-25
Publication Type
Article
Date
Jul-17-2015
Author
R M Carlsson
L. Gustafsson
H O Hallander
M. Ljungman
P. Olin
L. Gothefors
L. Nilsson
E. Netterlid
Source
Vaccine. 2015 Jul 17;33(31):3717-25
Date
Jul-17-2015
Language
English
Publication Type
Article
Keywords
Adolescent
Antibodies, Bacterial - blood
Child, Preschool
Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage - adverse effects - immunology
Drug-Related Side Effects and Adverse Reactions - epidemiology - pathology
Female
Humans
Immunization, Secondary - adverse effects - methods
Male
Sweden
Treatment Outcome
Whooping Cough - prevention & control
Abstract
Prior study children from a DTaP efficacy trial were recruited at ages 5 and 15 years to randomized booster trials addressing immunogenicity and reactogenicity; 475 preschool children received mixed or separate injections of a reduced antigen vaccine (Tdap5, Sanofi Pasteur MSD) and an inactivated polio vaccine, and 230 adolescents received the same or another booster vaccine (Tdap1, SSI, Denmark). Pre-vaccination antibody concentrations against pertussis antigens were significantly higher at 15 than 5 years of age, probably due to natural boosting between the studies. Tdap5 induced comparable anti-PT concentrations at both ages, but antibody responses were significantly higher to filamentous haemagglutinin, pertactin and fimbriae 2/3 in adolescents. As expected, a higher amount of PT (Tdap1, 20µg) induced a stronger anti-PT response than a lower amount (Tdap5, 2.5µg). The frequency of adverse events was low and there were no serious adverse reactions. All local reactions had an early onset and a short duration. A large swelling or redness of more than half of the upper arm circumference was reported in 8/475 5-year-olds and in 6/230 15-year-olds. Children vaccinated with Tdap5 reported more moderate pain in adolescence than at preschool age, whereas itching was only reported in preschool children. Sweden introduced DTaP vaccines in 1996 after a 17-year hiatus with no general pertussis vaccination and pertussis was still endemic at the time of the studies. The frequency of adverse events was nevertheless low in both preschool children and adolescents and antibody responses were adequate. These studies document immunogenicity and reactogenicity in a trial cohort consecutively vaccinated with acellular pertussis vaccines from infancy to adolescence. The adolescent study was registered at ClinicalTrials.gov on 26 March 2009 (NCT00870350).
PubMed ID
26057135 View in PubMed
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10 records – page 1 of 1.