A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data.


:The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person. In Guidelines section, the working group recommends to enable meaningful and standardized data collection, analysis, and presentation of information about a local reaction at or near the injection site. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographic region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance or epidemiologic study, or an individual report of a local reaction at injection site.






Gidudu J,Kohl KS,Halperin S,Hammer SJ,Heath PT,Hennig R,Hoet B,Rothstein E,Schuind A,Varricchio F,Walop W,Brighton Collaboration Local Reactions Working Group for a Local Reaction at or near Injection Site.




Has Abstract


2008-12-09 00:00:00
















  • Vaccination of sheep against M. paratuberculosis: immune parameters and protective efficacy.

    abstract::Johne's disease in ruminants is caused by the pathogenic bacterium Mycobacterium avium subspecies paratuberculosis (Map). Currently available Map commercial vaccines protect against clinical disease but not infection. In this study, the proprietary Johne's vaccine Neoparasec and an aqueous formulation of Map 316F (Aqu...


    pub_type: 临床试验,杂志文章


    authors: Begg DJ,Griffin JF

    更新日期:2005-10-10 00:00:00

  • Development of a high-dose vaccine formulation for prevention of megalocytivirus infection in rock bream (Oplegnathus fasciatus).

    abstract::A formalin-inactivated red sea bream iridovirus (RSIV) vaccine was prepared using the culture supernatant of a persistently infected Pagrus major fin cell line (PI-PMF) with IVS-1 strain (RSIV subtype II Meglaocytivirus). Rock bream (Oplegnathus fasciatus) were injected with a high-dose, ultracentrifuged megalocytivir...


    pub_type: 杂志文章


    authors: Kwon WJ,Choi JC,Hong S,Kim YC,Jeong MG,Min JG,Jeong JB,Kim KI,Jeong HD

    更新日期:2020-12-03 00:00:00

  • A systems approach to vaccine decision making.

    abstract::Vaccines reside in a complex multiscale system that includes biological, clinical, behavioral, social, operational, environmental, and economical relationships. Not accounting for these systems when making decisions about vaccines can result in changes that have little effect rather than solutions, lead to unsustainab...


    pub_type: 杂志文章


    authors: Lee BY,Mueller LE,Tilchin CG

    更新日期:2017-01-20 00:00:00

  • Penton-dodecahedron of fowl adenovirus serotype 4 as a vaccine candidate for the control of related diseases.

    abstract::In some serotypes of adenovirus (Ad), the penton base and attached trimeric fiber assemble into dodecameric virus-like particles called penton-dodecahedron (Pt-Dd), which can be internalized and used to deliver the vaccine antigens and drugs. Fowl adenovirus serotype 4 (FAdV-4) is an important pathogen, causing seriou...


    pub_type: 杂志文章


    authors: Wang X,Tang Q,Qiu L,Yang Z

    更新日期:2019-02-04 00:00:00

  • Hospital-based surveillance and molecular epidemiology of rotavirus infection in Taiwan, 2005-2007.

    abstract::To determine the distribution of rotavirus strains and facilitate vaccine policy decisions in Taiwan, active hospital-based gastroenteritis surveillance was conducted in three sentinel hospitals. From 1 January 2005 to 31 December 2007, a total of 3435 children less than 5 years old with gastroenteritis were enrolled....


    pub_type: 杂志文章


    authors: Wu FT,Liang SY,Tsao KC,Huang CG,Lin CY,Lin JS,Su CY,Eng HL,Yang JY,Chen PJ,Yang CF

    更新日期:2009-11-20 00:00:00

  • Effect of low level immunity on response to live rubella virus vaccine.

    abstract::Serum specimens of 1075 young adults representing nursing and medical staff were collected for determination of rubella immunity using the radial haemolysis (RH) technique, also know as the haemolysis in gel (HIG) test. Of the sera 84 (7.8%) were negative (RH titre less than 4 mm) and an additional 93 (8.7%) gave an R...


    pub_type: 杂志文章


    authors: Väänänen P,Mäkelä P,Vaheri A

    更新日期:1986-03-01 00:00:00

  • A strategy of antigen incorporation into exosomes: comparing cross-presentation levels of antigens delivered by engineered exosomes and by lentiviral virus-like particles.

    abstract::Among strategies aimed at developing new nanoparticle-based vaccines, exosomes hold much promise. They are nanovesicles released by basically all eukaryotic cell types originating from intraluminal vesicles which accumulate in multivesicular bodies. Exosomes have immunogenic properties whose strength correlates with t...


    pub_type: 杂志文章


    authors: Lattanzi L,Federico M

    更新日期:2012-11-26 00:00:00

  • Mucosal co-immunization of mice with recombinant lactococci secreting VapA antigen and leptin elicits a protective immune response against Rhodococcus equi infection.

    abstract::Rhodococcus equi causes severe pneumonia in foals and has recently gained attention as a significant opportunistic pathogen in immunocompromised humans. However, no effective vaccine to prevent rhodococcosis is currently available. In this study, we have engineered the food-grade bacterium Lactococcus lactis to secret...


    pub_type: 杂志文章


    authors: Cauchard S,Bermúdez-Humarán LG,Blugeon S,Laugier C,Langella P,Cauchard J

    更新日期:2011-12-09 00:00:00

  • A field vaccine trial in Tanzania demonstrates partial protection against malignant catarrhal fever in cattle.

    abstract::Malignant catarrhal fever (MCF) is a fatal lymphoproliferative disease of cattle that, in East Africa, results from transmission of the causative virus, alcelaphine herpesvirus 1 (AlHV-1), from wildebeest. A vaccine field trial involving an attenuated AlHV-1 virus vaccine was performed over two wildebeest calving seas...


    pub_type: 杂志文章,随机对照试验


    authors: Lankester F,Russell GC,Lugelo A,Ndabigaye A,Mnyambwa N,Keyyu J,Kazwala R,Grant D,Percival A,Deane D,Haig DM,Cleaveland S

    更新日期:2016-02-03 00:00:00

  • Enhancement of antibody response of turkeys to trivalent avian influenza vaccine by positively charged liposomal avridine adjuvant.

    abstract::Trivalent avian influenza (AIV) antigens (H4N8, H5N2 and H7N3), mixed with positively charged, negatively charged and neutral avridine-containing liposomes, and oil-emulsion were subcutaneously administered to 6-week-old turkeys. Charged liposomal avridine adjuvant, either positive or negative, produced a better antib...


    pub_type: 杂志文章


    authors: Fatunmbi OO,Newman JA,Sivanandan V,Halvorson DA

    更新日期:1992-01-01 00:00:00

  • Improving immunization data quality in Peru and Mexico: Two case studies highlighting challenges and lessons learned.

    abstract:INTRODUCTION:The Global Vaccine Action Plan and the Regional Immunization Action Plan of the Americas call for countries to improve immunization data quality. Immunization information systems, particularly electronic immunization registries (EIRs), can help to facilitate program management and increase coverage. Howeve...


    pub_type: 杂志文章


    authors: Trumbo SP,Contreras M,García AGF,Díaz FAE,Gómez M,Carrión V,Ruiz KJP,Aquije R,Danovaro-Holliday MC,Velandia-González M

    更新日期:2018-11-29 00:00:00

  • Poliovirus seroprevalence before and after interruption of poliovirus transmission in Kano State, Nigeria.

    abstract:INTRODUCTION:In September 2015, Nigeria was removed from the list of polio-endemic countries after more than 12months had passed since the detection of last wild poliovirus case in the country on 24 July 2014. We are presenting here a report of two polio seroprevalence surveys conducted in September 2013 and October 20...


    pub_type: 杂志文章


    authors: Iliyasu Z,Verma H,Craig KT,Nwaze E,Ahmad-Shehu A,Jibir BW,Gwarzo GD,Gajida AU,Weldon WC,Steven Oberste M,Takane M,Mkanda P,Muhammad AJG,Sutter RW

    更新日期:2016-09-30 00:00:00

  • The vaccine data link in Nha Trang, Vietnam: a progress report on the implementation of a database to detect adverse events related to vaccinations.

    abstract::Real, perceived and unknown adverse events secondary to vaccinations are a source of concern for care providers of children. In the USA large linked databases have provided helpful information regarding the safety of vaccines. Very little prospectively collected data on vaccine safety is available from resource poor c...


    pub_type: 杂志文章


    authors: Ali M,Canh DG,Clemens JD,Park JK,von Seidlein L,Thiem VD,Tho le H,Trach DD

    更新日期:2003-04-02 00:00:00

  • BoLA-DR peptide binding pockets are fundamental for foot-and-mouth disease virus vaccine design in cattle.

    abstract::This large study investigates the associations between bovine major histocompatibility complex DRB3 alleles and their binding pockets with the immune response to a 40-mer peptide derived from foot-and-mouth disease virus (FMDV) VP1. A crossbred (Charolais and Holstein) cattle population (n=197) was immunised with the ...


    pub_type: 杂志文章


    authors: Baxter R,Craigmile SC,Haley C,Douglas AJ,Williams JL,Glass EJ

    更新日期:2009-12-10 00:00:00

  • Single and booster dose responses to an inactivated hepatitis A virus vaccine: comparison with immune serum globulin prophylaxis.

    abstract::Pre- and postexposure prophylaxis against hepatitis A virus (HAV) infection with immune serum globulin (Ig) is only effective for 4-6 months. We compared the safety, tolerability and immunogenicity of a single i.m. injection of Ig with a single and booster dose of an inactivated hepatitis A virus vaccine (iHAV) in adu...


    pub_type: 临床试验,杂志文章


    authors: Shouval D,Ashur Y,Adler R,Lewis JA,Armstrong ME,Davide JP,McGuire B,Kuter B,Brown L,Miller W

    更新日期:1993-01-01 00:00:00

  • Analysis of efficacy of CVD 103-HgR live oral cholera vaccine against all-cause travellers' diarrhoea in a randomised, double-blind, placebo-controlled study.

    abstract::Enterotoxigenic Escherichia coli (ETEC), which produces heat labile toxin (LT) and/or heat stable toxin (ST), is considered to be the most common known cause of travellers' diarrhoea (TD). Owing to the antigenic similarity between cholera toxin and LT, immunization with inactivated oral B-subunit/whole-cell cholera va...


    pub_type: 杂志文章,随机对照试验


    authors: Leyten EM,Soonawala D,Schultsz C,Herzog C,Ligthelm RJ,Wijnands S,Visser LG

    更新日期:2005-10-17 00:00:00

  • Surveillance for adverse events after DTwP/Hib vaccination in Brazil: sensitivity and factors associated with reporting.

    abstract::We estimated the sensitivity, i.e., the proportion of all cases of adverse events following immunization (AEFIs) reported to the Brazilian passive surveillance for adverse events following immunization (PSAEFI) with the diphtheria-tetanus-whole-cell pertussis-Haemophilus influenzae type b (DTwP/Hib) vaccine, as well a...


    pub_type: 杂志文章


    authors: Monteiro SA,Takano OA,Waldman EA

    更新日期:2010-04-19 00:00:00

  • Potency against enterotoxemia of a recombinant Clostridium perfringens type D epsilon toxoid in ruminants.

    abstract::Enterotoxemia, a disease that affects domestic ruminants, is caused mainly by the epsilon toxin from Clostridium perfringens type D. Its eradication is virtually impossible, control and prophylaxis are based on systematic vaccination of herds with epsilon toxoids that are efficient in inducing protective antibody prod...


    pub_type: 杂志文章


    authors: Lobato FC,Lima CG,Assis RA,Pires PS,Silva RO,Salvarani FM,Carmo AO,Contigli C,Kalapothakis E

    更新日期:2010-08-31 00:00:00

  • A history of Panton-Valentine leukocidin (PVL)-associated infection protects against death in PVL-associated pneumonia.

    abstract::Panton-Valentine leukocidin (PVL) is a Staphylococcus aureus toxin associated with skin and soft-tissue infections (SSTIs) and life-threatening necrotizing pneumonia in humans. Recent reports have demonstrated that neutralizing antibody to PVL is not protective against SSTI recurrence, thus raising a controversy about...


    pub_type: 杂志文章


    authors: Rasigade JP,Sicot N,Laurent F,Lina G,Vandenesch F,Etienne J

    更新日期:2011-06-06 00:00:00

  • Effects of fungal N- and O-linked mannosylation on the immunogenicity of model vaccines.

    abstract::Targeting dendritic cell mannose receptors by mannosylating antigens represents a promising vaccination strategy. Using the model antigen ovalbumin (OVA) expressed recombinantly in bacterial and yeast vectors, we have previously demonstrated fungal mannosylation enhances antigen immunogenicity in the context of CD4(+)...


    pub_type: 杂志文章


    authors: Luong M,Lam JS,Chen J,Levitz SM

    更新日期:2007-05-30 00:00:00

  • Antigenicity and immunogenicity of HIV-1 gp140 with different combinations of glycan mutation and V1/V2 region or V3 crown deletion.

    abstract::The carbohydrate moieties on HIV-1 envelope glycoprotein (Env) act as shields to mask conserved neutralizing epitopes, while the hyperimmunogenic variable regions are immunodominant in inducing non-neutralizing antibodies, representing the major challenge for using Env as a vaccine candidate to induce broadly neutrali...


    pub_type: 杂志文章


    authors: Fu M,Hu K,Hu H,Ni F,Du T,Shattock RJ,Hu Q

    更新日期:2019-12-03 00:00:00

  • Modulation of immune responses in mice to recombinant antigens from PE and PPE families of proteins of Mycobacterium tuberculosis by the Ribi adjuvant.

    abstract::Three proteins of PE and PPE families of Mycobacterium tuberculosis were evaluated for their ability to induce T cell responses in mice. To enhance immunity induced by protein immunization, we tested the efficacy of adjuvant Ribi (monophosphoryl lipid A+TDM), along with three proteins of the PE/PPE family. Balb/c mice...


    pub_type: 杂志文章


    authors: Chaitra MG,Nayak R,Shaila MS

    更新日期:2007-10-10 00:00:00

  • Vaccination with a gE-negative bovine herpesvirus type 1 vaccine confers insufficient protection to a bovine herpesvirus type 5 challenge.

    abstract::In the present study, cross-protection to bovine herpesvirus type 5 (BHV-5) induced by bovine herpesvirus type 1 (BHV-1) vaccination was examined following inoculation of rabbits and calves with a glycoprotein E (gE)-negative BHV-1 vaccine and subsequent challenge with BHV-5. Rabbits (n=5) and calves (n=8) were vaccin...


    pub_type: 杂志文章


    authors: Silva AD,Spilki FR,Franco AC,Esteves PA,Hübner SO,Driemeier D,Oliveira AP,Rijsewijk F,Roehe PM

    更新日期:2006-04-12 00:00:00

  • A bivalent conjugate vaccine in the treatment of biochemically relapsed prostate cancer: a study of glycosylated MUC-2-KLH and Globo H-KLH conjugate vaccines given with the new semi-synthetic saponin immunological adjuvant GPI-0100 OR QS-21.

    abstract::GPI-0100 is a semi-synthetic saponin with modifications designed to augment stability and diminish toxicity. Two batches of GPI-0100 (the second with higher purity) were tested with doses ranging between 100 and 5000 microg in groups of five treated prostate cancer patients who had no evidence of disease except for ri...


    pub_type: 杂志文章


    authors: Slovin SF,Ragupathi G,Fernandez C,Jefferson MP,Diani M,Wilton AS,Powell S,Spassova M,Reis C,Clausen H,Danishefsky S,Livingston P,Scher HI

    更新日期:2005-05-02 00:00:00

  • Long-term seropositivity, safety, and impact of inactivated and live, attenuated hepatitis a vaccines in China - A cross-sectional study.

    abstract:BACKGROUND:In 2008, China introduced live, attenuated hepatitis A vaccine (L-HepA, licensed in 1992) and inactivated hepatitis A vaccine (I-HepA, licensed in 2002) nationwide, and is currently the only country using L-HepA in routine immunization. We assessed seropositivity and its duration following vaccination, safet...


    pub_type: 杂志文章


    authors: Xiaojin S,Rodewald LE,Guomin Z,Hui Z,Ning M,Fuzhen W,Zundong Y

    更新日期:2020-12-14 00:00:00

  • Burkholderia pseudomallei and Burkholderia mallei vaccines: Are we close to clinical trials?

    abstract::B. pseudomallei is the cause of melioidosis, a serious an often fatal disease of humans and animals. The closely related bacterium B. mallei, which cases glanders, is considered to be a clonal derivative of B. pseudomallei. Both B. pseudomallei and B. mallei were evaluated by the United States and the former USSR as p...


    pub_type: 杂志文章,评审


    authors: Titball RW,Burtnick MN,Bancroft GJ,Brett P

    更新日期:2017-10-20 00:00:00

  • Expression and characterization of a novel truncated rotavirus VP4 for the development of a recombinant rotavirus vaccine.

    abstract::The outer capsid protein VP4 is an important target for the development of a recombinant rotavirus vaccine because it mediates the attachment and penetration of rotavirus. Due to the poor solubility of full-length VP4, VP8 was explored as candidate rotavirus vaccines in the past years. In previous studies, it has been...


    pub_type: 杂志文章


    authors: Li Y,Xue M,Yu L,Luo G,Yang H,Jia L,Zeng Y,Li T,Ge S,Xia N

    更新日期:2018-04-12 00:00:00

  • Immunogenic properties of chimeric protein from espA, eae and tir genes of Escherichia coli O157:H7.

    abstract::Enterohemorrhagic Escherichia coli (EHEC) comprise an important group of enteric pathogens causing hemorrhagic colitis and hemolytic uremic syndrome. These bacteria need EspA (E) as a conduct for Tir (T) delivery to the host cell and surface arrayed intimin (I) which docks the bacterium to the translocated Tir. This p...


    pub_type: 杂志文章


    authors: Amani J,Salmanian AH,Rafati S,Mousavi SL

    更新日期:2010-10-04 00:00:00

  • A global perspective of vaccination of healthcare personnel against measles: systematic review.

    abstract::Measles transmission has been well documented in healthcare facilities. Healthcare personnel who are unvaccinated and who lack other evidence of measles immunity put themselves and their patients at risk for measles. We conducted a systematic literature review of measles vaccination policies and their implementation i...


    pub_type: 杂志文章,评审


    authors: Fiebelkorn AP,Seward JF,Orenstein WA

    更新日期:2014-08-27 00:00:00

  • Inclusion of the murine IgGκ signal peptide increases the cellular immunogenicity of a simian adenoviral vectored Plasmodium vivax multistage vaccine.

    abstract:INTRODUCTION:Cellular and humoral immune responses are both involved in protection against Plasmodium infections. The only malaria vaccine available, RTS,S, primarily induces short-lived antibodies and targets only a pre-erythrocytic stage antigen. Inclusion of erythrocytic stage targets and enhancing cellular immunoge...


    pub_type: 杂志文章


    authors: Fonseca JA,McCaffery JN,Caceres J,Kashentseva E,Singh B,Dmitriev IP,Curiel DT,Moreno A

    更新日期:2018-05-11 00:00:00